Events

Rappel de Device Recall AppleHunt Secondary Cannula/Pyramidal Tip Trocar

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 CooperSurgical, 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
    79825
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1584-2018
  • Date de mise en oeuvre de l'événement
    2018-03-12
  • 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=163601
  • 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
    Trocar - Product Code DRC
  • Cause
    Products have been packaged with the wrong trocar length type.
  • Action
    On March 26, 2018 CopperSurgical Inc. mailed a Medical Device Recall Notification to affected customers. Customers were instructed to discontinue the use of the affected lot number 223333 and complete an Acknowledgement and Receipt Form to schedule refund or exchanges. If customers supplied products to any other facility, they have been asked to provide the recipients a copy of the notification letter. Customers with questions may contact CopperSurgical at recall@coopersurgical.com.

Device

Device Recall AppleHunt Secondary Cannula/Pyramidal Tip Trocar
  • Modèle / numéro de série
    Lot number 223333
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of FL, GA, IN, NJ, and countries of Canada, Austria, Chile, Italy, Singapore
  • Description du dispositif
    5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 || Product Usage: || The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky external valves, fittings, or housings. The ergonomic trocar design is simple to use and features a smooth cannula/trocar transition for easier sleeve insertion and reduced risk of patient injury.
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Adresse du fabricant
    CooperSurgical, Inc., 95 Corporate Dr, Trumbull CT 06611-1350
  • Société-mère du fabricant (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA