Events

Retiro De Equipo (Recall) de Device Recall Epix and Direct Drive Laparoscopic Graspers

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Applied Medical Resources Corp.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    65217
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1521-2013
  • Fecha de inicio del evento
    2013-05-01
  • Fecha de publicación del evento
    2013-06-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118293
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Laparoscopic accessories, gynecologic - Product Code NWV
  • Causa
    Applied medical is conducting a voluntary recall on specific lot numbers of its epix¿ and direct drive laparoscopic graspers. when the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. the likelihood of this situation to occur and result in permanent patient injury is highly unlikely;.
  • Acción
    Applied Medical notified customers of the recall beginning on May 13, 2013. The "URGENT: MEDICAL DEVICE RECALL" letter identified the product, problem, and actions to be taken by the customers. For questions regarding this notice, contact the firm at (949) 713-8041.

Device

Device Recall Epix and Direct Drive Laparoscopic Graspers
  • Modelo / Serial
    Model Numbers C4130 and C4140.  MODEL NUMBERS    C4130- 5mm x 35cm Epix/Direct Drive Laparoscopic Grasper  LOT NUMBERS  1145332, 1145943, 1145944, 1145945, 1145992, 1145993, 1145994, 1146371, 1147900, 1147901, 1147955, 1148172, 1148173, 1148174, 1148180, 1148181, 1148184, 1148190, 1148191, 1148192, 1148194, 1148201, 1148203, 1148677, 1148765, 1148766, 1148767, 1148835, 1149040, 1149041, 1149690, 1149757, 1150168, 1150169, 1150170, 1150490, 1150634, 1151246, 1151247, 1151248, 1152274, 1152728, 1153332, 1154394, 1154637,  1155135, 1155473, 1155948, 1156004, 1156010, 1156011, 1156012, 1156270, 1156360, 1156452, 1156577, 1156857, 1157218, 1157679, 1157950, 1157951, 1157952, 1157953, 1157954, 1158052, 1158131, 1158216, 1158217, 1158425, 1159491, 1160167, 1161136, 1161137, 1161398, 1161638, 1162112, 1162503, 1162504, 1162588, 1163399, 1163558, 1163559, 1163575, 1164580, 1164581, 1164582, 1164583, 1168124, 1168637, 1168638, 1169117, 1171168, 1171631, 1172170, 1172668, 1173153, 1174995, 1174996, 1176616, 1177407, 1177408, 1178109, 1180295, 1181554, 1182940, 1183774, 1184416, 1184959, 1187241, 1188110, 1188745, 1189773, 1191368, 1191809.  C4140- 5mm x 45cm Epix/Direct Drive Laparoscopic  Grasper  1145559, 1147851, 1147852, 1147960, 1148210, 1148211, 1149038, 1149039, 1149689, 1149936, 1150488, 1150489, 1151249, 1152594, 1153330, 1155645, 1157217, 1157949, 1158644, 1160033, 1160170, 1162111, 1167871, 1169855, 1171497, 1172009, 1173587, 1174121, 1177578, 1179347, 1180753, 1181346, 1182924, 1183769, 1184961, 1188111, 1189182  Various Kits Containing Either C4130 or C4140 1148079, 1148139, 1148145, 1148250, 1148514, 1148770, 1148780, 1149100, 1149605, 1150455, 1151831, 1153074, 1153702, 1154931, 1154997, 1155332, 1156581, 1156812, 1157090, 1158535, 1160152, 1160227, 1160388, 1161766, 1162189, 1162343, 1163348, 1163881, 1164590, 1164796, 1164831, 1165443, 1166520, 1168227, 1169190, 1169456, 1169620, 1169772, 1170151, 1170378, 1171280, 1171878, 1171879, 1172330, 1173319, 1173903, 1174093, 1175987, 1175991, 1176171, 1178210, 1178498, 1178581, 1179376, 1182679, 1182972, 1183303, 1184673, 1185599, 1185762, 1186257, 1186868, 1187082, 1188827, 1189581, 1190574, 1191055, 1193112, 1193147, 1193648, 1193688, 1194964,  1194965
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Jordan, Kuwait, Malaysia, Lebanon, Lybia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Spain, South Africa, Switzerland, Taiwan-Province of China,Turkey, United Arabs Emirates United Kingdom, Uruguay, and Venezula-Bolivarian Republic.
  • Descripción del producto
    Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. || Used for grasping and manipulating tissue during general or laparoscopic surgery.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Dirección del fabricante
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Empresa matriz del fabricante (2017)
    Applied Medical Corporation
  • Source
    USFDA