Events

Rappel de Device Recall A20975A: Working insert, with ramp, one way; A20976A: Bridge, one way; A20977A; Bridge, two way

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 Corporation of the Americas.

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
    79017
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0696-2018
  • Date de mise en oeuvre de l'événement
    2017-08-18
  • 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=161176
  • 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
    Endoscope, ac-powered and accessories - Product Code GCP
  • Cause
    Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. cracking, chipping, missing pieces, and delamination of the adhesive have also been reported. in one case, a fragment of the adhesive was detected inside a patient's urethra during a procedure and was retrieved without injury to the patient. the manufacturer, olympus winter & lbe gmbh ("owi") has determined that adhesive can be dislodged during the intended use of the cystoscopy bridge or working insert, e.G., when inserting an instrument through the working channel. as a result, a fragment of the adhesive may fall inside the patient's bladder, urethra or uterus and would need to be retrieved, extending the length of the procedure or requiring additional surgical treatment. the adhesive is used to seal gaps inside the working channel of the cystoscopy bridges and working inserts. in 2013, the adhesive used until then was discontinued and had to be replaced. current investigations revealed that the durability of the new adhesive is insufficient.
  • Action
    On August 18, 2017 an URGENT Medical Device Removal and Corrective Action letter was sent to customers regarding the "Cystoscopy Bridges and Working Inserts" instructing customers to review their inventory, quarantine affected product and call customer service at 800-848-9024 to arrange return and replacement.

Device

Device Recall A20975A: Working insert, with ramp, one way; A20976A: Bridge, one way; A20977A; B...
  • Modèle / numéro de série
    Model Numbers and Associated Lot Numbers: A20975A -- 13-ZW to 172W A20976A -- 146W to 172W A20977A -- 146W to 174W
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) || Product Usage: || A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.
  • Manufacturer
    Olympus Corporation of the Americas

Manufacturer

Olympus Corporation of the Americas
  • Adresse du fabricant
    Olympus Corporation of the Americas, 3500 Corporate Pkwy, PO Box 610, Center Valley PA 18034-0610
  • Société-mère du fabricant (2017)
    Olympus Corporation
  • Source
    USFDA