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 surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed

Recall number

Z-0109-2024

Recalling firm

Olympus Corporation of the Americas

Product

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 surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed

Status

Open, Classified

Initiated

2023-09-12

Posted

2023-10-12

Terminated

not on file

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 representative at 1-800-848-9024, option 2, with the quantity, model, and lot number of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification: a. Go to https://olympusamerica.com/recall. b. Enter the recall number: 0431 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1.

Quantity

271 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

UDI-DI: 4953170409684 Lot Numbers: KR310806 KR310809 KR313734 KR319658 KR326619 KR326628 KR333661 Lots Added January 11, 2024: KR310806 KR310809 KR333661 KR342666

510(k) numbers

["K211838"]

PMA numbers

not on file

Product code

LFL

Firm FEI

2429304

Firm city

Center Valley

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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