Recall Z-0351-2025 ยท GCP Endoscope, Ac-Powered And Accessories
Olympus Corporation of the Americas
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
| Date | Nov 8, 2024 (initiated Sep 13, 2024) |
| Status | Open, Classified |
| Reason | Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe. |
| Root cause | Under Investigation by firm |
| Action | On October 11, 2024 URGENT: MEDICAL DEVICE CORRECTION letters were sent to consignees. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above-listed device. 3. You should not use the Cystoscope Outer sheath, 22.5 French with a GreenLight Laser for BPH therapy until further notice from Olympus. Add a copy of this letter to any on-hand copies of the Instructions for Use. 4. Olympu |
| Quantity | 738 units |
| Distribution | US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K790071 | ENDOSCOPE AND ACCESSORIES Olympus Corp., Apr 2, 1979 |