THUNDERBEAT Open Fine Jaw Type X TB-0009OFX (UDI 04953170394577)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04953170394577), received between Oct 19, 2022 and Mar 12, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL INSTRUMENT TISSUE PAD IN THE GRASPING SECTION WAS WORN AWAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581695 ↗
• MalfunctionNov 20, 2025Naturally Worn; Naturally Worn

  DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE TISSUE PAD IN THE GRASPING SECTION OF THE THUNDERBEAT DEVICE WAS WORN. NO PATIENTS WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611987 ↗
• MalfunctionAug 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE THUNDERBEAT JAW CLAMP BECAME DETACHED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22880076 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THE TIP OF THE THUNDERBEAT BROKE OFF DURING A PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436036 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT UPON USING THE THUNDERBEAT AROUND THE UTERUS DURING A PROCEDURE THE TIP BROKE AND DETACHED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276208 ↗
• MalfunctionJun 20, 2024Material Separation; Material Separation

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC SURGICAL DEVICE EXHIBITED A PART OF THE TISSUE PAD WAS PEELED AWAY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576149 ↗
• MalfunctionMay 6, 2024Peeled/Delaminated; Peeled/Delaminated

  THE ISSUE OCCURRED 10 MINUTES FROM THE END OF A THYROIDECTOMY PROCEDURE CAUSING A 15 MINUTE PROCEDURAL DELAY. A NON-DISPOSABLE BIPOLAR FORCEPS WAS USED TO COMPLETE THE PROCEDURE WITHOUT THE ENERGY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249956 ↗
• MalfunctionSep 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE GRIP OF THE THUNDERBEAT OPEN FINE JAW TYPE X BROKE AT THE BASE. THE ISSUE OCCURRED DURING A THERAPEUTIC HEPATECTOMY PROCEDURE. THE GRIP PART FELL OFF WHEN THE NURSE, WHO TOOK OUT THE INSTRUMENT, WAS CLEANING THE TIP TISSUE PAD WITH GAUZE. THE NURSE WAS CLEANING THE BURN PART. THE GRIP BROKE IMMEDIATELY WITHIN AN HOUR AFTER THE START OF THE OPERATION. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17791975 ↗
• MalfunctionSep 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE WIPER JAW OF THE THUNDERBEAT OPEN FINE JAW TYPE X BROKE WHEN THE NURSE WAS WIPING OFF DIRT. THE ISSUE OCCURRED ABOUT EIGHT HOURS AFTER STARTING THE THERAPEUTIC PANCREATECTOMY PROCEDURE. THE CUSTOMER CONFIRMED THE METAL PART OF THE WIPER JAW WAS THE BROKEN INSERTION PART. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17791899 ↗
• MalfunctionAug 9, 2023Fracture; Fracture

  AN OLYMPUS TERRITORY MANAGER REPORTED ON BEHALF OF A CUSTOMER, DURING AN UNSPECIFIED PROCEDURE A THYROID THUNDERBEAT DID NOT WORK AS EXPECTED. THE TIP BROKE OFF AND WAS BURNT. THE TIP DID NOT FALL WITHIN THE PATIENT¿S CAVITY. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494554 ↗
• MalfunctionJul 6, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE INSIDE OF THE ISOLATED CLAW CAME LOOSE A BIT WHILE USING THE FIRST DEVICE. THE ULTRASONIC GENERATOR GAVE AN ERROR MESSAGE WHILE USING ANOTHER DEVICE AND THE DEVICE MUST BE REPLACED. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED ISSUE. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE TISSUE PAD IN THE GRASPING SECTION WAS WORN AWAY, AND A PART OF THE TISSUE PAD WAS PEELED AWAY. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (WORN AND PEELED TISSUE PAD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17274062 ↗
• MalfunctionApr 24, 2023Fracture; Fracture

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING AN EVENTRATION PROCEDURE AFTER FIVE MINUTES F USING THE THUNDERBEAT DEVICE, THE DEVICE TIP BROKE OFF. THE PROCEDURE WAS COMPLETED WITH A NEW SIMILAR DEVICE. THERE IS NO CONSEQUENCE, HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795583 ↗
• MalfunctionOct 19, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, APPROXIMATELY TWO HOURS INTO A THERAPEUTIC OPEN LIVER RESECTION PROCEDURE, AN UNKNOWN OUTPUT ERROR WAS RECEIVED FOR THE DEVICE WHEN SHORT-PITCH OUTPUT WAS CONTINUED FOR ABOUT 10 MINUTES. THE DOCTOR CONTINUED TO USE THE DEVICE BUT THE ERROR MESSAGES CONTINUED. THE DEVICE WAS REMOVED FROM THE PATIENT BODY FOR CHECKING. THE DEVICE TISSUE PAD WAS PEELED BACK. THE PROCEDURE WAS COMPLETED WITH A NEW SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE SETTINGS AT THE TIME WERE SEAL AND CUT1, SEAL 3. THE INTELLIGENT TISSUE MONITORING (ITM) SETTING WERE ON DURING THE PROCEDURE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NTOED. PER THE DOCTOR, THE CASE WAS COMPLEX COMPARED TO NORMAL SUCH CASES. THE DOCTOR IS A REGULAR USER OF THE DEVICE OFJ TYPE OF THUNDERBEAT. THIS DEVICE IS OFX TYPE WHICH IS NEW AND IMPROVED. THE DEVICE WAS BEING USED TO DEMONSTRATE THE QUALITIES OF THE DEVICE. A FALSE OSCILLATION WAS PERFORMED WHICH CONTRIBUTED TO THE EVENT. THE DOCTOR NOW UNDERSTANDS THE DEVICE USAGE AND WHAT LED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633141 ↗