Class 2 Device Recall Thunderbeat

• Date Initiated by Firm: September 12, 2023
• Date Posted: October 12, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0109-2024
• Recall Event ID: 93071
• 510(K)Number: K211838
• Product Classification: Instrument, ultrasonic surgical - Product Code LFL
• 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
• Code Information: UDI-DI: 4953170409684 Lot Numbers: KR310806 KR310809 KR313734 KR319658 KR326619 KR326628 KR333661 Lots Added January 11, 2024: KR310806 KR310809 KR333661 KR342666
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: SAME; 484-896-5000
• Manufacturer Reason for Recall: 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
• FDA Determined 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 in Commerce: 271 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LFL and Original Applicant = Olympus Medical Systems Corporation