Recall Z-1814-2022 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olympus Corporation of the Americas
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
| Date | Sep 26, 2022 (initiated Aug 12, 2022) |
| Status | Open, Classified |
| Reason | An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment |
| Root cause | Under Investigation by firm |
| Action | Olympus issued Urgent Medical Device Recall Letter on 8/12/22 to Surgical Department Risk Management. Letter states reason for recall, health risk and action to take: 1. Immediately locate any product with affected lot numbers listed in this communication. See Attachment 2 for pictures showing the location of lot numbers on the package. 2. Call your Olympus customer service representative at 1 800 848 9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of affected product |
| Quantity | 231.4 units (5/box); 510 units (5/box) OUS |
| Distribution | Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA |
| 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 |