THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip TB-0545FCRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170337543), received between Oct 19, 2017 and Mar 10, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 22, 2025Class IIOpen, Classified

   Firm is initiating a removal due to continued reports of adverse events.

   Z-1374-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING AS THUNDERBEAT. THE JAW BROKE INSIDE THE PATIENT. THE USER WAS ABLE TO RETRIEVE THE BROKEN PIECE AND FINISH THE PROCEDURE WITH NO FURTHER CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13722517 ↗
• MalfunctionOct 30, 2019Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE THUNDERBEAT TB-0545FC STOPPED WORKING AND AN ERROR CODE OCCURRED. CUSTOMER DID NOT SPECIFY WHAT ERROR CODE WAS OBSERVED DURING THE INCIDENT. THERE WAS NO HARM OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9255549 ↗
• MalfunctionOct 17, 2019Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE DOCTOR USED THE THUNDERBEAT TB-0545FC AND LAID IT DOWN ON A DRAPE. IT WAS REPORTED THAT THE TIP BURNED A HOLE ON THE DRAPE AND THE DOCTOR WANTED THE TIP TO BE INSPECTED. FIELD REPRESENTATIVE STATED THAT THE DOCTOR WAS VERY EXPERIENCED IN USING THE THUNDERBEAT. THERE WAS NO PATIENT/USER INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9204214 ↗
• MalfunctionJan 10, 2019Crack; Peeled/Delaminated; Crack; Peeled/Delaminated

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, THE TEFLON PAD FROM THE GRASPING SECTION OF THE DEVICE WAS PEELING AND THE PROBE UNIT CRACKED. IT WAS REPORTED THAT SURGEON WAS PERFORMING A SEAL/CUT ON THE PATIENT¿S TISSUE, WHEN A ¿PROBE DAMAGE¿ ERROR MESSAGE WAS OBSERVED ON THE GENERATOR. THE GENERATOR SETTINGS WERE 2 CUT/1 COAG. NO DEVICE FRAGMENT FELL INTO THE PATIENT. THERE WAS NO BLEEDING OBSERVED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONALLY, THE USER FACILITY REPORTED THAT THE DEVICE AND THE GENERATOR CONNECTION POINTS WERE INSPECTED PRIOR TO THE PROCEDURE WITH NO ANOMALIES FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8238510 ↗
• MalfunctionJul 24, 2018Overheating of Device; Overheating of Device

  OLYMPUS WAS INFORMED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE TEFLON PAD FROM THE GRASPING SECTION OF THE DEVICE BURNT AND PEELED BACK EXPOSING METAL. IT WAS REPORTED THAT SIMULTANEOUSLY, A "PROBE DAMAGE" ERROR MESSAGE WAS OBSERVED ON THE GENERATOR. THE SURGEON WAS PERFORMING THE SEAL/CUT FUNCTION WHEN THE TEFLON PAD DAMAGE OCCURRED. THERE WAS NO BLEEDING REPORTED. NO DEVICE FRAGMENT FELL INTO THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONALLY, THE USER FACILITY REPORTED THAT THE DEVICE AND THE CONNECTION POINTS WERE INSPECTED PRIOR TO THE PROCEDURE WITH NO ANOMALIES FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716666 ↗
• MalfunctionJul 24, 2018Overheating of Device; Overheating of Device

  OLYMPUS WAS INFORMED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE TEFLON PAD FROM THE GRASPING SECTION OF THE DEVICE BURNT AND PEELED BACK EXPOSING METAL. IT WAS REPORTED THAT SIMULTANEOUSLY, A "PROBE DAMAGE" ERROR MESSAGE WAS OBSERVED ON THE GENERATOR. THE SURGEON WAS PERFORMING THE SEAL/CUT FUNCTION WHEN THE TEFLON PAD DAMAGE OCCURRED. THERE WAS NO BLEEDING REPORTED. NO DEVICE FRAGMENT FELL INTO THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONALLY, THE USER FACILITY REPORTED THAT THE DEVICE AND THE CONNECTION POINTS WERE INSPECTED PRIOR TO THE PROCEDURE WITH NO ANOMALIES FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716650 ↗
• MalfunctionOct 19, 2017Device Operates Differently Than Expected

  THUNDERBEAT (OLYMPUS) DEVICE SENSOR MALFUNCTION, "CHECK FOR METAL IN JAWS OF DEVICE".

  Patient problems: No Information

  MAUDE report 6961389 ↗