THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S TB-0545FCS (UDI 04953170383526)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04953170383526), received between Aug 27, 2018 and Mar 11, 2024 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

2 FDA recall records name this device's identifier, 2 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-1371-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 25, 2024Class IIOpen, Classified

   The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

   Z-0999-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2024Break; Detachment of Device or Device Component; Thickening of Material; Break; Detachment of Device or Device Component; Thickening of Material

  IT WAS REPORTED, THE THUNDERBEAT COAGULATES WITHOUT CUTTING, AND AFTER IT WARMS UP, IT BREAKS AFTER 20 MINUTES. THE ISSUE CAUSED AN ADDITIONAL 25-MINUTE PROCEDURAL TIME. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882740 ↗
• InjuryJun 9, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THERAPEUTIC LAPAROSCOPIC SURGERY, ONE OF THE TWO PROBES OF THIS ULTRASONIC SURGICAL DEVICE, BROKE AND FELL INTO THE PATIENT'S ABDOMEN. THE GENERATOR WENT INTO ALARM BECAUSE THE FORCEPS COULD NO LONGER FUNCTION. THE PIECE WAS IMMEDIATELY RECOVERED AND THE CLAMP ISOLATED. ADDITIONAL INFORMATION RECEIVED THAT THE OPERATING MODE WAS COAGULATION. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. NO PROCEDURE DELAY. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100908 ↗
• MalfunctionOct 27, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE UPPER JAW OF THE SUBJECT DEVICE BROKE OFF AND FELL INTO THE PATIENT DURING A THERAPEUTIC GASTRIC SLEEVE/BYPASS PROCEDURE. THE TIP WAS RETRIEVED. THE TIP SEPARATED WHILE APPLYING SEAL & CUT SETTING. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680781 ↗
• MalfunctionJan 12, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC HEPATECTOMY PROCEDURE, THE PROBE TIP OF THE DEVICE BROKE OFF AFTER ONE ACTIVATION. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT¿S BODY BY GRASPING. THE PROCEDURE WAS COMPLETED WITH A ANOTHER SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE USER SUSPECTED THE DURABILITY OF THE DEVICE AS A RESULT OF THIS EVENT. THE DEVICE WAS INSPECTED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13238402 ↗
• MalfunctionAug 10, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE PROBE TIP WAS BROKEN DURING A THERAPEUTIC PROCEDURE. THE BROKEN TIP COULD BE RETRIEVED FROM THE PATIENT'S BODY. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298925 ↗
• MalfunctionJul 9, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE PROBE TIP WAS BROKEN WITHOUT ANY REASON DURING THE THERAPEUTIC PROCEDURE,. THE USER FACILITY TOOK OUT A BROKEN TIP BY GRASPING IT FROM THE PATIENT BODY. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12141258 ↗
• MalfunctionJul 6, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING THE PROCEDURE USING THE SUBJECT DEVICE, THE PROBE WAS BROKEN OFF. THE FRAGMENT WAS RETRIEVED IMMEDIATELY FROM INSIDE THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119910 ↗
• MalfunctionJun 23, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE PHYSICIAN THAT DURING AN UNSPECIFIED PROCEDURE USING THE SUBJECT DEVICE, THE PROBE WAS BROKEN OFF INTO THE PATIENT AND AN UNSPECIFIED ERROR OCCURRED. THE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055265 ↗
• MalfunctionMay 24, 2021Melted; Melted

  THE DEVICE WAS RETURNED FOR INTERMITTENT BI-POLAR FUNCTIONALITY ISSUE DURING THE PROCEDURE. AT THE TIME OF INSPECTION, IT WAS OBSERVED THAT A PORTION OF THE TEFLON PAD CHARRED, THINNED OUT, AND WORN OUT AT THE EDGES, THUS CREATING A VOID AND EXPOSING A SMALL PORTION OF METAL. THERE IS NO REPORTED HARM TO THE PATIENT. THE PATIENT PROCEDURE WAS COMPLETED WITH THE SAME DEVICE BY GRASPING THE TISSUE AND ACTIVATING THE DEVICE TO REGISTER A MISFIRE; THEN RE-GRASPING THE TISSUE TO REACTIVATE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872526 ↗
• MalfunctionMay 5, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING A TOTAL GASTRECTOMY USING THE SUBJECT DEVICE, THE PROBE WAS BROKEN OFF. THE FRAGMENT WAS RETRIEVED FROM INSIDE THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781035 ↗
• MalfunctionMay 3, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE FOLLOWING REPORT FROM THE USER. DURING THE TOTAL GASTRECTOMY, THE SUBJECT DEVICE WAS USED. WHEN THE DEVICE WAS ACTIVATED ABOUT TWO OR THREE TIMES, THE PROBE TIP WAS BROKEN OUT INSIDE OF THE PATIENT BODY. AS THE BROKEN TIP COULD BE FOUND OUT VISUALLY, THE USER COULD TAKE IT OUT IMMEDIATELY FROM THE PATIENT BODY. THE PROCEDURE WAS TERMINATED WITH A REPLACEMENT OF THE SAME SET OF EQUIPMENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766959 ↗
• MalfunctionApr 29, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING A TOTAL GASTRECTOMY USING THE SUBJECT DEVICE, THE PROBE WAS BROKEN OFF INSIDE THE PATIENT. THE BROKEN TIP COULD BE RETRIEVED FROM THE PATIENT BODY. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750915 ↗
• MalfunctionApr 5, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE UPPER JAW WAS BENT, ALTHOUGH INITIALLY THE DEVICE HAD PERFORMED CORRECTLY. THERE WAS AN AUDIBLE ALARM. WHEN THE USER CHECKED THE SUBJECT DEVICE OUTSIDE THE PATIENT, THE JAW WAS SEPARATED AND FELL OFF. THE INTENDED PROCEDURE WAS CONTINUED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613289 ↗
• MalfunctionMay 21, 2019Break; Break

  DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE SUBJECT DEVICE WAS USED. THE PROBE OF THE SUBJECT DEVICE BROKE OFF AND FELL INSIDE THE PATIENT BODY. THE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE PROBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626992 ↗
• MalfunctionAug 27, 2018Break; Break

  DURING A SLEEVE GASTRECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE TISSUE PAD OF THE SUBJECT DEVICE WAS PEELED OFF. THE INTENDED PROCEDURE WAS COMPLETED WITH SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE PEELED OFF OF THE TISSUE PAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7817256 ↗