Intuitive Surgical, Inc.

All systems manufactured with or upgraded to P5 software.

General and Plastic Surgery Devices

2

No

Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Qatar, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; || General and Plastic Surgery: || The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, || endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic || surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.

Product number: 950156-01: Lot numbers: NQ141201 NQ141502 NQ142201 NQ142901 NQ143201 NQ143301.  Product number 950156-02: Lot numbers: NQ143501 NQ143502 NQ143601 NQ143602 NQ143803 NQ143901 NQ143902.  Product number 950156-03: Lot numbers : NQ144001 NQ150501  NQ143902 NQ150601  NQ143901 NQ150602  NQ143803 NQ150703  NQ143601 NQ150701  NQ143602 NQ150702  NQ144502 NQ150801  NQ144801 NQ150901  NQ145202 NQ150802  NQ144901 NQ151001  NQ145301 NQ151002  NQ145201 NQ151101  NQ150301 NQ150501  NQ144001.

General and Plastic Surgery Devices

2

No

US Nationwide Distribution

Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; || Model numbers: 950156-01, 950156-02, 950156-03. || Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.

EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.

General and Plastic Surgery Devices

2

No

US Nationwide Distribution.

EndoWrist Stapler 45 instrument for the da Vinci Si System || Model Number: IS3000 || Product Usage: || For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Part Number: PN 410322-04, -05  Serial Numbers: SH1484 SH1879 SH1875 SH1485 USG332 SH0561 USG803 SH1406 SH1405 SH0034 SH0554 SH0554 USG160 USG575 SH0908 SH2066 SH1455 SH0975 SH1475 SH1168 SH1552 SH0608 SH0608 SH1756 SH1716 USG071 USG038 SH0607 SH1590 SH1686 SH1639 SH1688 SH1740 SH1932 USG323 SH1944 USG286 SH1945 SH2022 SH2085 SH1108 SH2047 USG257 USG435 USG183 SH2079 USG035 USG144 USG647 SH1590 USG641 SH0087 USG580 SH0389 USG106 SH1642 USG351 SH0280 SH1963 SH0566 USG551 USG566 USG636 SH2076 USG122 USG163 SH0084 USG706 USG563 SH0252 SH1494 SH1249 SH1588 SH1495 USG103 USG484 SH0329 SH1980 USG060 USG421 USG364 SH0148 USG398 SH0412 SH0881 SH1687 SH2154 SH1998 SH1802 SH1863 SH1939 SH2100 SH2128 SH0572 SH0208 SH1159 SH1592 SH0273 SH2143 SH1297 SH1852 SH2014 SH1941 SH2009 SH2015 SH2013 SH2027 SH2116 SH2056 SH2012 SH2161 SH2193 SH2209 SH0467 SH0238 USG605 SH1962 SH1757 SH1874 SH1938 SH1607 SH1854 SH2096 SH2070 SH2082 SH2095 USG560 USG279 SH1608 USG726 SH1114 SH1614 SH2054 USG116 USG277 USG345 SH2179 SH2207 SH0328 SH1901 SH1940 SH0733 SH0658 SH0062 SH0357 SH1691 SH0893 USG129 SH1565 SH2121 USG418 SH1806 USG127 USG159 USG438 SH1118 SH0030 SH0332 SH0586 SH0819 SH0435 USG445 SH0108 USG156 SH0436 SH0883 SH0950 SH1096 SH1336 SH1369 SH0306 SH0640 SH0481 SH0453 SH1282 SH1177 SH0341 SH0850 SH1192 SH1293 SH0214 SH0319 SH0078 SH0741 SH0949 SH1391 SH1372 SH1322 SH1362 SH1401 SH1353 SH0098 SH0592 SH1027 SH0181 USG098 USG639 SH0212 SH1375 SH1359 SH1213 SH1337 SH0582 SH1332 SH0802 SH1396 SH0475 SH1394 SH1338 SH0438 SH1367 SH1409 SH1348 SH0829 SH1395 SH1376 USG542 SH0118 SH1389 SH1142 SH1402 SH0379 SH1399 SH1294 SH0830 SH1287 SH1398 SH1335 SH0394 SH1392 SH0483 SH1383 SH1347 SH1325 SH0321 USG623 SH0115 SH0770 SH1412 SH1343 USG334 SH0599 SH1410 SH0847 SH0962 SH1466 SH0168 SH0415 SH0159 SH1413 SH0041 SH1446 SH0418 SH1427 SH0318 SH0921 SH0723 SH1451 SH1022 SH0613 USG114 SH0314 SH1504 SH0476 SH0142 SH1432 SH0729 SH0722 USG221 USG515 SH0837 SH1438 SH0299 SH0609 SH0966 SH1109 SH0169 USG533 USG558 SH0417 SH1512 SH1426 SH1276 SH1448 SH1323 SH1247 SH1460 SH0755 SH1197 SH1344 SH1334 SH1331 SH0052 SH0275 SH0986 SH0753 SH0386 SH1273 USG170 SH1364 SH0486 SH0919 SH1457 USG311 SH1515 SH1518 SH1513 SH1441 SH1373 SH1505 SH1471 USG059 SH1197 SH1417 USG696 SH1415 SH1445 SH0767 SH1487 SH1193 SH1124 SH1194 SH0420 SH1093 SH0423 SH0898 SH0413 SH0165 SH1414 SH0863 SH1295 USG074 SH0768 SH0849 SH1425 SH1418 SH1440 SH1506 USG649 SH1431 SH1182 SH1162 SH0466 SH1430 USG2007 SH0920 SH0641 SH0548 SH1462 SH1496 SH1472 SH0314 SH0742 SH1488 SH1489 SH0584 SH1478 SH1459 SH1508 USG135 SH1453 SH0575 SH1491 USG565 SH1477 SH1467 SH1549 SH1191 SH0248 SH1521 SH0843 SH1483 SH1524 SH1449 SH1479 USG498 SH1436 SH1234 SH1437 SH1447 SH0861 USG248 USG343 SH1014 SH0489 SH1433 SH0739 SH0983 SH1469 SH1261 USG2011 SH1529 SH0838 SH1429 SH1055 SH1497 SH1498 SH1490 SH1510 SH1511 SH1305 SH1517 SH0101 USG056 SH0130 SH0325 SH0784 SH1532 SH0109 SH0934 SH1288 SH1526 SH0152 SH1144 SH0485 SH0039 SH1223 SH0700 SH0241 SH0970 SH0576 SH1545 USG567 SH1326 SH1069 SH1351 SH0951 SH0022 SH0297 SH0922 SH0792 SH1525 USG172 SH1576 USG631 USG700 SH1566 SH1324 SH1465 USG412 SH0281 SH0725 SH0716 SH1147 USG342 SH1530 SH0751 SH0673 USG440 SH0025 SH0674 SH1008 SH1363 SH0149 SH1522 SH1575 SH0266 SH1553 USG048 SH1146 SH1136 SH0985 SH1534 SH1452 USG469 SH1268 SH1540 USG433 SH0113 USG707 SH0984 SH1531 SH0183 SH1034 SH1251 SH1533 SH1128 SH0368 SH1553 SH0431 SH1578 SH1258 SH1679 SH1539 USG643 SH0903 SH1188 SH0904 SH0685 SH0633 USG132 SH0786 SH1556 SH1206 USG213 SH1672 SH1680 SH0073 SH1645 SH1677 SH0499 SH1232 USG193 SH1564 SH1570 SH1568 SH1628 SH1667 SH0498 USG436 SH1612 USG768 SH1651 SH0358 USG548 USG340 SH0120 SH1390 SH0172 SH1684 SH0597 SH1583 SH1464 SH1622 SH1619 SH1236 SH1623 SH0915 SH1626 SH1620 SH1632 SH1032 USG316 SH1624 SH1630 SH1602 SH0081 USG525 SH1635 SH1637 SH0400 SH1286 USG508 SH1606 SH1132 SH1591 SH0505 SH0963 SH1165 SH1106 SH1101 SH0234 SH0335 USG333 SH1690 SH1609 SH0255 SH1604 SH1574 SH1605 SH0529 SH1038 SH1581 SH1217 SH0045 SH1594 SH0455 SH1580 SH1584 SH1593 SH1577 SH1051 SH1631 SH1634 USG616 SH1280 SH0080 SH0750 SH1029 SH0914 SH1616 USG419 SH1611 SH1629 SH1633 SH1646 USG769 SH0078 SH1664 SH1648 SH0590 SH0789 SH1270 SH1013 SH0858 SH0076 SH1649 SH1636 SH1643 SH1476 SH1660 SH0302 SH0503 SH1665 SH1652 SH1641 SH1669 SH0512 SH1670 SH1673 SH0501 SH1654 USG367 SH1663 USG773 SH0079 SH0946 SH0259 USG538 SH1689 SH1308 SH0160 SH1309 SH0543 SH0134 SH1666 SH0127 SH1668 SH1219 SH0793 SH0032 SH1709 SH1706 SH0981 USG621 SH0261 SH1107 USG611 SH1157 SH0776 SH0870 USG689 USG104 SH1719 SH0395 SH1458 SH1707 SH0889 SH1454 SH0873 SH1285 SH0040 SH1585 SH0618 SH0360 SH0452 SH1092 SH0611 SH1699 SH0798 SH1218 SH0521 SH0296 SH0470 SH1355 SH0670 SH1442 SH1317 SH1089 SH1048 USG775 SH0835 SH1767 USG653 SH1765 SH1116 SH1763 SH1761 SH1710 SH1003 USG065 SH1729 SH0545 SH0651 SH0401 USG622 SH0021 SH0477 SH1068 SH1717 SH0186 SH0778 SH0714 SH1731 SH1728 SH0695 SH1711 SH0382 SH1760 SH1291 USG092 SH1138 SH1764 SH1366 USG226 SH1744 SH1748 SH0715 SH1737 SH0848 SH1198 USG788 SH0300 SH1746 SH1743 USG393 USG749 SH1131 SH1773 USG404 USG645 USG188 SH0823 SH0253 SH0973 SH1770 SH0474 SH1739 SH0312 SH1769 SH0187 SH0240 USG243 SH1732 SH1736 SH1290 SH1745 SH1735 SH1794 USG518 SH0272 USG434 SH0048 USG559 USG013 USG028 SH1312 SH1752 SH1384 SH0069 SH0348 USG250 SH1610 SH1741 SH1772 USG573 SH1790 SH1753 SH1747 SH0482 SH1793 SH1786 SH1215 SH1791 SH0571 SH0309 USG529 SH1778 SH1775 SH1792 USG655 USG232 SH1783 SH1780 SH1787 SH0806 SH0646 SH0648 SH0876 SH0464

General and Plastic Surgery Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, China, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. || The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.

PATIENT SIDE CART, PS4000.  Part Number: 380652 Serial Numbers: 353668 351929 354943 351749 354389 351849 355824 363594 361993 360419 358104 357083 351852 351845 361323 358107 364412 364505 361994 364001 349166 364112 358774 359361 357082 363784 353632 364343 358109 358848 351052 354234 354552 356258 363752 354233 358775 364200 359222 364619 363868 354714 361989 361391 361094 351853 353410 355206 357698 358480 365395 359223 355996 363681 360417 355623 365465 365839 356530 364620 365928 365862 356532 366904 366884 367674 368046 367426 356683 360413 356533 368071 368681 358930 357081.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US nationwide and the countries of: Belgium, Germany, China(Hong Kong), India, Israel, Italy, and the United Kingdom.

ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. || Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.