Events

Rappel de Device Recall Cholangioscopy Access Balloon

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 Cook Endoscopy.

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
    57573
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0926-2011
  • Date de mise en oeuvre de l'événement
    2010-12-23
  • Date de publication de l'événement
    2011-01-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96679
  • 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
    Catherer, biliary, diagnostic - Product Code FGE
  • Cause
    There is a risk of gastrointestinal perforation or air embolism due to balloon deflation difficulty, resulting in poor patient outcomes.
  • Action
    The firm, Cook Medical, sent an "URGENT: PRODUCT RECALL" letter dated January 7, 2011, to all customers. The letter described the product, problem and the actions to be taken by the customers. The customers were instructed to quarantine any affected product and return to Cook Medical. If they are distributors, they were instructed to contact their customers, direct them to quarantine any affected product and coordinate the return of the affected product to Cook Medical. The customers were also instructed to complete and return the bottom of the letter and send to Cook Medical as well as the PRODUCT RECALL EFFECTIVENESS SURVEY via fax at 812-339-7316 or scanned and emailed to CustomerRelationsNA@cookmedical.com. Note: All non-responding customers will receive a total of three (3) recall notifications ( two (2) follow up requests for a response in addition to the initial recall notification). Should you have any questions, please contact the Customer Relations Department at Cook Medical for more information. Please use CustomerRelationsNA@cookmedical.com or call toll free at 1-800-457-4500, press 4 then enter extension 2146.

Device

Device Recall Cholangioscopy Access Balloon
  • Modèle / numéro de série
    DPOC-20, Lot number: W2834631
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands..
  • Description du dispositif
    DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical, Winston-Salem, NC 27105 || This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
  • Manufacturer
    Cook Endoscopy

Manufacturer

Cook Endoscopy
  • Adresse du fabricant
    Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA