Class 2 Device Recall A20975A: Working insert, with ramp, one way; A20976A: Bridge, one way; A20977A; Bridge, two way

• Date Initiated by Firm: August 18, 2017
• Create Date: February 23, 2018
• Recall Status: Terminated on July 07, 2020
• Recall Number: Z-0696-2018
• Recall Event ID: 79017
• 510(K)Number: K790071
• Product Classification: Endoscope, ac-powered and accessories - Product Code GCP
• Product: 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.
• Code Information: Model Numbers and Associated Lot Numbers: A20975A -- 13-ZW to 172W A20976A -- 146W to 172W A20977A -- 146W to 174W
• FEI Number: 2429304
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; PO Box 610; Center Valley PA 18034-0610
• For Additional Information Contact: 484-896-5000
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Component change control
• 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.
• Quantity in Commerce: 8741
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GCP