Class 2 Device Recall Thunderbeat

• Date Initiated by Firm: September 12, 2023
• Date Posted: October 12, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0108-2024
• Recall Event ID: 93071
• 510(K)Number: K211838
• Product Classification: Instrument, ultrasonic surgical - Product Code LFL
• Product: THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS 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: 4953170409677 Lot Numbers: KR271978 KR314612 KR314613 KR314615 KR314617 KR314618 KR314619 KR314621 KR314622 KR314623 KR314624 KR314626 KR314627 KR314628 KR314629 KR314630 KR314631 KR314632 KR314633 KR314634 KR314638 KR314640 KR314641 KR314644 KR314647 KR314648 KR314650 KR314651 KR314652 KR314654 KR314655 KR314657 KR314659 KR314660 KR314662 KR314663 KR314668 KR314670 KR314671 KR314672 KR314673 KR314674 KR314675 KR314676 KR314679 KR316617 KR316627 KR316629 KR316637 KR316683 KR319616 KR319643 KR319655 KR332609 KR332615 KR332616 KR332623 KR332626 KR335733 KR335754 KR335760 KR335769 KR335770 KR335776 KR335781 KR335784 KR335785 KR335794 KR335796 KR335836 PW308606 PW308607 PW308609 PW308611 PW308613 PW308615 PW308616 PW308663 PW308772 PW308773 PW308774 PW308775 PW308776 PW308786 PW308788 Lots Added January 11, 2024: KR271978 KR314619 KR314627 KR314633 KR314648 KR335770 KR310806 KR314612 KR314621 KR314628 KR314634 KR332616 KR335836 KR310809 KR314613 KR314622 KR314629 KR314638 KR332623 KR333661 KR314615 KR314623 KR314630 KR314640 KR332626 KR342666 KR314617 KR314624 KR314631 KR314641 KR335754 KR314618 KR314626 KR314632 KR314644 KR335769
• FEI Number: 2429304
• 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: 2496 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