Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus Corporation of the Americas.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79017
  • Event Risk Class
    Class 2
  • Event Number
    Z-0696-2018
  • Event Initiated Date
    2017-08-18
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161176
  • Notes / Alerts
    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.
  • Extra notes in the data
    Endoscope, ac-powered and accessories - Product Code GCP
  • Reason
    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...
  • Model / Serial
    Model Numbers and Associated Lot Numbers: A20975A -- 13-ZW to 172W A20976A -- 146W to 172W A20977A -- 146W to 174W
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    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
  • Manufacturer Address
    Olympus Corporation of the Americas, 3500 Corporate Pkwy, PO Box 610, Center Valley PA 18034-0610
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA