THUNDERBEAT Open Extended JawRecalls & reported problems across all models

We found 2 models of THUNDERBEAT Open Extended Jaw by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2016 and Sep 21, 2026 — classified as 9 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Break” (60 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported THUNDERBEAT Open Extended Jaw problems

THUNDERBEAT Open Extended Jaw models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• THUNDERBEAT Open Extended Jaw TB-0920OE

  Instrument, ultrasonic surgical
  63 reports
• THUNDERBEAT Open Extended Jaw TB-0920OE

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  18 reports

Recent THUNDERBEAT Open Extended Jaw adverse event reports

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

• MalfunctionSep 21, 2026Naturally Worn

  The customer returned the Thunderbeat device to the service center for evaluation related to a separate issue. During the evaluation, a reportable malfunction was identified: the tissue pad was worn out. There was no patient involvement associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841272 ↗
• MalfunctionSep 1, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546602 ↗
• MalfunctionMay 20, 2026Material Fragmentation

  IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S PROBE HAD BROKEN EDGES THAT FELL WITHIN THE PATIENT ANATOMY DURING AN ABDOMINAL PERINCOL RESECTION FOR RECTAL CANER. THE DEVICE FRAGMENT WAS RETRIEVED WITH FORCEPS AND RESULTED IN A DELAY TO THE PROCEDURE OF LESS THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH A BACK-UP OLYMPUS DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234752 ↗
• MalfunctionMay 20, 2026Degraded

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232259 ↗
• MalfunctionJan 27, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189533 ↗
• MalfunctionNov 4, 2025Device Reprocessing Problem; Material Separation; Detachment of Device or Device Component; Device Reprocessing Problem; Material Separation; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE TEFLON PAD WAS DAMAGED AND HAD A MISSING PORTION WHICH WAS EXPOSING THE METAL JAW. THE DISTAL END HAD INDICATIONS OF DRIED RESIDUE ON THE JAW AND PROBES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472552 ↗
• MalfunctionSep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC DEVICE EXHIBITED THAT THE TISSUE PAD IS SPLIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23102680 ↗
• MalfunctionJun 9, 2025Degraded; Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE THUNDERBEAT EXHIBITED WORN OF THE TISSUE PAD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172096 ↗
• MalfunctionMar 27, 2025Naturally Worn; Naturally Worn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE REAR END OF THE TISSUE PAD WAS WORN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706482 ↗
• InjuryJan 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN LIVER SURGERY UNDER SEDATION, THE THUNDERBEAT'S PROBE BROKE AND APPROXIMATELY 1CM GOT STUCK IN THE LIVER. IT WAS RETRIEVED WITH NO DAMAGE TO THE SURROUNDING TISSUE AND THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21119410 ↗
• MalfunctionNov 8, 2024Material Separation; Material Separation

  IT WAS REPORTED, THE ULTRASONIC SURGICAL DEVICE BROKE DURING USE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642482 ↗
• InjurySep 17, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE ULTRASONIC SURGICAL DEVICE PROBE BROKE OFF AND FELL INTO THE PATIENT CAVITY DURING A THERAPEUTIC LAPAROSCOPIC OOPHORECTOMY PROCEDURE. THERE WAS A TWO MINUTE DELAY TO RETRIEVE THE PART WITH GRASPING FORCEPS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241739 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE JAW PROBE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223339 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THE ULTRASONIC SURGICAL DEVICE BLADE BROKE OFF IN THE ABDOMINAL AREA. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT BODY, RESULTING IN A SLIGHT DELAY. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOUROLOGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983294 ↗
• MalfunctionJul 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, WHILE USING THE ULTRASONIC SURGICAL DEVICE, AFTER 2-3 MINUTES OF INTERVENTION ONE OF THE TWO PROBES OF THE TB-SCISSOR BROKE (AND DETACHED FROM THE DEVICE). THE BROKEN PIECE FELL OUTSIDE THE PATIENT'S BODY. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THE PATIENT DID NOT REQUIRE ADDITIONAL ANESTHESIA, THERE WAS NO PROLONGED HOSPITALIZATION AND NO OTHER INTERVENTION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691676 ↗

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