Events

Retiro De Equipo (Recall) de Device Recall CAPSure; Coblator; CoVAC; ArthroWand; Microblastor; Saber; Saphyre; SERFAS; TriStar; VARP; Vulcan.

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 Surgical Instrument Service And Savings, Inc..

¿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
    65205
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1628-2013
  • Fecha de inicio del evento
    2013-05-03
  • Fecha de publicación del evento
    2013-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118246
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
  • Acción
    MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.

Device

Device Recall CAPSure; Coblator; CoVAC; ArthroWand; Microblastor; Saber; Saphyre; SERFAS; TriSta...
  • Modelo / Serial
    122029, 122295, 122486, 122577, 122734, 122654, 123266, 122651, 122427, 122630, 122494, 122595, 122419, 122446, 122308, 122671, 122455, 122593, 122626, 122483, 123044, 122283, 122466, 122673, 122745, 122589, 122306, 122356, 122435, 122502, 122639, 122293, 122663, 122325, 122512, 122765, 122765, 122762, 122409, 122318.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 || -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 || -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot 122494 || -Coblator II Evac 70 Xtra Plasma Wand, w/Integrated Saline Line & Integrated Cable. Ref. EIC 5872-01 Lot 122295, 122308, 122626, 122325, || -Coblator II, ENT ReFlex Ultra 45 w/Integrated Cable, (Blue). Ref. EIC 4845-01 Lot 122651, 122419, 122671, 122633 || Electrosurgical cutting and coagulation device and accessories. || -CoVac 50, Suction ArthroWand, w/Integrated Cable, (White/Grey). Ref. ASC 2530-01 Lot 122483, 122745 || -CoVac 70, ICW ArthroWand 70 angle 3.0mm. Ref. ASC 3730-01 Lot 122483, || -Eliminator, Right Angle ArthroWand (Beige). Ref. A 1345-01 Lot 122446 || -Eliminator, Right Angle ArthroWand, 90 Degree w/Integrated Cable, (Grey) 4.5mm. Ref. AC 1345-01 Lot 122494, 122446 || -ENT Coblator II PROcise XP Wand, w/Integrated Cable, Suction & Saline, (Blue). Ref. EIC 8872-01 Lot 122651, 122762 || -Ligament Chisel Probe,Curved w/Integrated Cable, (Grey/Green). Ref. 7209647 Lot 122512 || -LightWave Suction Ablator, 90 Degree, Hand Control, Multi-Angle, (Blue/White) 4.5mm x 142mm. Ref. IA-2000-S Lot 122512 || -Lo-Pro 90 Degree ArthroWand, w/Integrated Cable, (Grey) 3.6mm. Ref. AC1336-01 Lot 122654, 122325 || -Meniscectomy Electrode, Standard Design (Grey) 165mm. Ref. C5010A Lot 122765 || -MeniVac ArthroWand w/Suction, w/Integrated Cable, (Grey) 3.0mm. Ref. ASC 5500-01 Lot 122630, 122494 || -Microblastor 30 Wand, 30 Degree, w/Integrated Cable, (Grey) 0.9mm Tip. Ref. AC 40500-01 Lot 122293 || -Right Angle ArthroWand, 90 Degree, w/Integrated Cable, (Grey) 3.5mm. Ref. AC 1340-01 Lot 123044, 122673 || -Saber 30 ArthroWand, 30 Degree, w/Integrated Cable, (Grey) 3.0mm. Ref. AC 4330-01 Lot 122630, 122494, 123044, 122283, 122765 || -SAPHYRE II Bipolar Ablation Probe, w/suction, High Profile 50 Degree, (Pewter). Ref. 7210112 Lot 122734 || -SERFAS ENERGY Hook Probe 3.5mm. Ref. 279-350-501 Lot 123266 || -Small Joint ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey/White) 2.3mm. Ref. AC 2823-01 Lot 122494, 122663 || -StarVac ArthroWand, Short Bevel 35, w/Integrated Cable, Suction (Grey)5.5mm. Ref. ASC 4251-01 Lot 122630, 122593, 122483, 123044, 122283, 122595 || -Super MultiVac 50, 50 Degree, w/Suction and Integrated Cable, (Grey/Black) 3.0mm. Ref. ASC 4830-01 Lot 122029, 123044, 122663 || -Super TurboVac 90, 90 Degree Suction ArthroWand, (White/Grey) 3.5mm. Ref. ASC 4250-01 Lot 122029,122654, 122651, 122427, 122630, 122494, 122626, 122745, 122293, 122663, 122325, 122765 || -TAC-C II Probe, w/Integrated Cable, (Blue/Grey). Ref. 7209628 Lot 122486 || -TriStar 50 Suction ArthroWand, 50 Degree w/Integrated Cable, (White/Grey). Ref. ASC 4630-01 Lot 122283 || -Turbinate, Tissue Coagulating Electrode, (White). Ref. 1120-4110-01 Lot 122486 || -VAPR Hook Electrode W/Integrated Handpiece 3.5mm. Ref. 227305 Lot 122288, 122466 || -VAPR LD, Suction Electrode, Large Diameter (Blue) 4.0mm. Ref. 225360 Lot 122512 || -VAPR Premiere50-, w/Integrated Cable, Suction, (Black/White) 3.0mm. Ref. 227504 Lot 122029, 122455 || -VAPR Premiere90 w/Suction tion, Integrated Cable, (Black/White) 3.3mm. Ref. 227204 Lot 122029, 122446, 122466, 122306, 122435, 122293, || -VAPR S90 Suction Electrode, w/Integrated Cable, (Black/White). Ref. 225370 Lot 122577, 122455, 122593, 122288, 122466, 122589, 122356, 122639, 122325, 122318 || -VAPR Side Effect Electrode (Blue) 3.5mm. Ref. 225301 Lot 122512 || -VAPR Side Effect Electrode, w/Integrated Handpiece 3.5mm. Ref. 227301 Lot 122288, 122356, || -VAPR Wedge Electrode (Short,) w/Integrated Cable (Black/White) 2.3mm x 85 mm. Ref. 227213 Lot 122409 || -VAPR Wedge Electrode, w/Integrated Cable (Black/White) 2.3mm. Ref. 227203 Lot 122486, 122639 || -VAPR Angled, Side Effect Electrode (Blue) 3.5mm. Ref. 225302 Lot 122512 || -Vulcan Sa
  • Manufacturer
    Surgical Instrument Service And Savings, Inc.

Manufacturer

Surgical Instrument Service And Savings, Inc.
  • Dirección del fabricante
    Surgical Instrument Service And Savings, Inc., 2747 Sw 6th St, Redmond OR 97756-7109
  • Empresa matriz del fabricante (2017)
    Medline Industries Inc.
  • Source
    USFDA