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THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, lapar...

FDA Device Recall #Z-0108-2024 — Class II — September 12, 2023

Recall Summary

Recall Number Z-0108-2024
Classification Class II — Moderate risk
Date Initiated September 12, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Olympus Corporation of the Americas
Location Center Valley, PA
Product Type Devices
Quantity 2496 units

Product Description

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

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

Distribution Pattern

US Nationwide distribution.

Lot / 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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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