Events

Rappel de Device Recall SPIDER ADVANCED Surgical Platform

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 Transenterix, Inc.

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
    58093
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1910-2011
  • Date de mise en oeuvre de l'événement
    2011-02-25
  • Date de publication de l'événement
    2011-04-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98333
  • 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
    Laparoscope, general &, plastic surgery - Product Code GCJ
  • Cause
    Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.
  • Action
    TransEnterix sent an Urgent Device Recall letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the lot numbers affected, complete the attached inventory reconciliation form and return the form, along with any affected product to TransEnterix using the enclosed shipping label. Customers were asked to return the inventory form even if they had none of the lot numbers affected in their inventory. Their sales representative and customer service will work with them to replace the product in full at not cost to them. For questions regarding this recall contact TransEnterix Customer Care at 1-888-879-4111.

Device

Device Recall SPIDER ADVANCED Surgical Platform
  • Modèle / numéro de série
    Model number: 9000021, Lot numbers: TRX056201001,  TRX061201002, TRX071201001, TRX086201003.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AZ, FL, NC, NY, OH, OR, SC, TX, VA and WA
  • Description du dispositif
    SPIDER ADVANCED Surgical Platform || The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.
  • Manufacturer
    Transenterix, Inc

Manufacturer

Transenterix, Inc
  • Adresse du fabricant
    Transenterix, Inc, 635 Davis Dr Ste 300, Morrisville NC 27560-7183
  • Société-mère du fabricant (2017)
    Transenterix Inc.
  • Source
    USFDA