Events

Rappel de Device Recall Olympus SD Snares

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 Olympus America 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
    55663
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2236-2010
  • Date de mise en oeuvre de l'événement
    2010-05-03
  • Date de publication de l'événement
    2010-08-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91483
  • 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
    Flexible Snare - Product Code FDI
  • Cause
    An investigation of consumer complaints revealed the inability of the snare wire to be retracted into the snare tube after deployment of the snare.
  • Action
    Firm initiated this recall following investigation of customer complaints regarding the inability of the snare wire to be retracted into the snare tube. Customers were notified via certified mail, an Urgent: Medical: Device Recall letter issued on May 4, 2010. The letter identified the affected product and the reason for the recall. Customers were instructed to inspect their inventory and identify the affected product. Customers are to remove from use any identified inventory, quarantine, and discard them. Customers should contact the firm to obtain replacement products. Questions should be directed towards Laura Storms-Tyler at 484-896-5688 or laura.storms-tyler@olympus.com.

Device

Device Recall Olympus SD Snares
  • Modèle / numéro de série
    Snare Package Lot numbers: 9YK, 9ZK, 01K, 02K, & 03K.  Snare Tube Lot Numbers: K9Y10, K9Y16, K9Y18, K9Y19, KDY20, K9Y24, K9Y25, K9Y26, K9Y27, K9Y30,K9Z01, K9Z02, K9Z03, K9Z04, K9Z07, K9Z08, K9Z09, K9Z10, K9Z11, K9Z14,K9Z15, K9Z16, K9Z17, K9Z18, K9Z21, K9Z22, K9Z24, K9Z25, K9Z28, K9Z29, K0105, K0106, K0107, K0108, K0112, K0113, K0114, K0115, K0118, K0119, K0120, K0121, K0122, K0127, K0129, K0202, K0203, K0204, K0205, K0208, K0209, K0210, K0212, K0215, K0216, K0217, K0218, K0222, K0224,K0225, K0226, K0301, K0302, K0303, K0305, K0308, K0309, K0310, K0311, K0312, K0315, and K0316.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- AR, CA, CO, CT, DC, FL, GA, IN, KS, LA, MD, MO, NC, NY, OH, PA, SC, TN, and TX.
  • Description du dispositif
    Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. || To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract.
  • Manufacturer
    Olympus America Inc.

Manufacturer

Olympus America Inc.
  • Adresse du fabricant
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • Société-mère du fabricant (2017)
    Olympus Corporation
  • Source
    USFDA