Recall Z-0109-2024 ยท LFL Instrument, Ultrasonic Surgical
Olympus Corporation of the Americas
THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surg
| Date | Oct 12, 2023 (initiated Sep 12, 2023) |
| Status | Open, Classified |
| Reason | Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery |
| Root cause | Under Investigation by firm |
| Action | UPDATE: Olympus issued a revised letter for additional lots titled: Correction to letter dated September 13, 2023- Additional Lot numbers on January 11, 2024. Olympus issued Urgent Medical Device Recall Letter on 9/13/23 to Healthcare Professional. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any THUNDERBEAT models and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. The lot number can be found on the box or pouch. 2. Call your Olympus customer service rep |
| Quantity | 271 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211838 | Ultrasonic Bipolar Generator USG-410 with accessories Olympus Medical Systems Corporation, Aug 4, 2021 |