Events

Rappel de Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Gripper Grasper

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Teleflex Medical.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    78340
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0059-2018
  • Date de mise en oeuvre de l'événement
    2017-10-18
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159243
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.
  • Action
    Teleflex sent an Urgent Medical Device Recall 1st Notification letter dated October 18, 2017, via FedEx. The customers were instructed to take the following actions : 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter." For further questions please call (847) 572- 8014.

Device

Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Gripper Grasper
  • Modèle / numéro de série
    (a) Catalog Number PCVJG5, Lot Numbers: 73E1700794, 73G1700271, 73G1700515, 73H1700081, 73H1700367  (b) Catalog Number PCVMD5, Lot Numbers: 73E1700796, 73G1700273,  73H1700083  (c) Catalog Number PCVHCA5, Lot Numbers: 73E1700798, 73H1700084  (d) Catalog Number PCVGG5, Lot Numbers: 73E1700793, 73G1700272, 73H1700082, 73H1700247  (e) Catalog Number PCVSC5, Lot Number: 73H1700569
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore.
  • Description du dispositif
    Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: || (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 || (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 || (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 || (d) 5 mm Traumatic Gripper Grasper, Catalog Number PCVGG5 || (e) 5 mm Scissors, Catalog Number PCVSC5 || The Percuvance Percutaneous Surgical System is a family of instruments used to perform laparoscopic procedures. Without the need for additional insertion conduits (trocars), the 2.9mm insulated Shafts are inserted percutaneously with the assistance of an Introducer needle tool tip. The Shaft is then advanced retrograde through a 5mm, or larger, port to facilitate the extracorporeal attachment of interchangeable Tool Tips. These interchangeable tools can be used to grasp, retract, manipulate, cut, coagulate and deliver Hem-o-lok¿ ligating clips to soft tissue. Each Percuvance System Handle includes an integrated male cautery adapter that can be connected to most monopolar electrosurgical units (ESU) via a standard 4mm monopolar cable.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA