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THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S

OLYMPUS MEDICAL SYSTEMS CORP. · Model TB-0535FCS · UDI-DI 04953170383540

LFLGEI Prescription
10
510(k) clearances
68,850
Adverse events (81 deaths)
109
Recalls
141
Facilities

Description

THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S

Recalls

DateFirmReason
2026-03-06Integra LifeSciences Corp. (NeuroSciences)Software issue that renders the touch screen unresponsive.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.