Recall Z-0696-2018 ยท GCP Endoscope, Ac-Powered And Accessories
Olympus Corporation of the Americas
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 treatmen
| Date | Aug 18, 2017 |
| Status | Terminated |
| 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 c |
| Root 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 | 8741 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K790071 | ENDOSCOPE AND ACCESSORIES Olympus Corp., Apr 2, 1979 |