Recall Z-1700-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olympus Corporation of the Americas
POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA
| Date | Apr 30, 2024 (initiated Mar 7, 2024) |
| Status | Open, Classified |
| Reason | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery. |
| Root cause | Process control |
| Action | Olympus issued Urgent Medical Device Removal Letter on April 2, 2024 via email/visit. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any POWERSEAL products having the lot number identified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lots. 2. Please contact Customer Service at at 1-800-848-9024, option 2, with the quantity, model and lot number of the affected device(s). Olympus will issue a Return Material Authorization to return |
| Quantity | 850 units: (400 units US);(450 units OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double Action Olympus Surgical Technologies America, Sep 27, 2021 |