THUNDERBEAT Open Extended Jaw TB-0920OE (UDI 04953170343308)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04953170343308), received between Jun 14, 2018 and Sep 21, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18 most recent of 18 reports, 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, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 21, 2023Break; Break

  THE CUSTOMER REPORTED THE JAW OF THE THUNDERBEAT OPEN EXTENDED JAW BROKE OFF DURING AN OPEN THERAPEUTIC HEMICOLECTOMY PROCEDURE. THE CUSTOMER NOTED THAT OTHER THUNDERBEATS WERE USED WITHOUT PROBLEMS. THE DEVICE WAS DISCARDED AT THE SITE BY THE CUSTOMER. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17792447 ↗
• MalfunctionApr 9, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE FOLLOWING REPORT FROM THE USER. DURING THE PROCEDURE, THE PROBE OF THE SUBJECT DEVICE WAS BROKEN WITHOUT ANY REASON(FUNCTIONAL MODE: SEAL&CUT MODE 1). THE USER TOOK OUT A BROKEN TIP BY GRASPING IT FROM THE PATIENT BODY. THE PROCEDURE WAS TERMINATED WITH A REPLACEMENT OF THE SAME SET OF EQUIPMENT. BUT THE USER SUSPECTED THE DURABILITY OF THE PRODUCT BECAUSE OF THIS CASE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11639574 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE RECEIVED THE FOLLOWING REPORT. DURING A HEMI COLECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, UNINTENDED CONTACT WITH THE DEVICE CAUSED BURN AND PERFORATION. THE PERFORATION WAS RECOGNIZED AT THE TIME AND ADDRESSED ACCORDINGLY. THE INTENDED PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED INTERVENTION PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THE SUBJECT DEVICE WAS DISCARDED BY THE USER.

  Patient problems: Burn, Thermal; Perforation

  MAUDE report 10360458 ↗
• MalfunctionJul 15, 2020Break; Break

  DURING A COLECTOMY, THE SUBJECT DEVICE WAS USED. AFTER 30 MINUTES OF THE START OF THE PROCEDURE, THE PROBE OF THE SUBJECT DEVICE WAS BROKEN OFF AND FELL INSIDE THE PATIENT. 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 10275503 ↗
• MalfunctionMar 25, 2020Break; Break

  DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE SUBJECT DEVICE STOPPED WORKING. THE TISSUE PAD WAS MELTED. THERE WAS NO PATIENT INJURY REPORTED. ON MARCH 4, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD WAS SEVERELY WORN. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881460 ↗
• MalfunctionFeb 28, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  AS REPORTED FOR THIS EVENT, DURING THE PROCEDURE THE DEVICE JAW BROKE OFF. THERE WAS NO ADVERSE IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED, COMPLETION DEVICE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9769344 ↗
• MalfunctionSep 30, 2019Break; Break

  DURING A HEMICOLECTOMY, THE SUBJECT DEVICE WAS USED. WHEN THE SUBJECT DEVICE WAS CONNECTED WITH THE GENERATOR, PROBE DAMAGE ERROR OCCURRED. THE USER CONTINUOUSLY DISCONNECTED AND CONNECTED THE SUBJECT DEVICE BUT THE GENERATOR ALERTED TO REPLACE THE DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE COATING FOR ELECTRIC INSULATION OF THE GRASPING SECTION WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE MISSING OF THE GRASPING SECTION COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9137741 ↗
• MalfunctionJul 10, 2019Break; Break

  DURING A LOWER ANTERIOR RESECTION, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE PROBE BROKE OFF INSIDE THE PATIENT. 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 8779044 ↗
• MalfunctionMay 10, 2019Break; Break

  DURING A KNEE AMPUTATION, THE SUBJECT DEVICE WAS USED. THE BLEEDING COULD NOT BE STOPPED SINCE AN U509 ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8598535 ↗
• MalfunctionOct 12, 2018Break; Break

  OLYMPUS WAS INFORMED THAT THE END OF A VAGINAL HYSTERECTOMY PROCEDURE, THE PROBE AT THE DISTAL TIP OF THE DEVICE BROKE OFF AND FELL INTO THE PATIENT¿S VAGINAL CAVITY. IT WAS REPORTED THAT A PROBE ERROR OCCURRED AND THE DEVICE WAS DISCONNECTED AND RECONNECTED. A SUCCESSFUL PROBE CHECK WAS INITIATED. AFTER A PERIOD OF TIME, THE PROBE DETACHED. THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED AS THE PROBE WAS QUICKLY RETRIEVED FROM THE PATIENT BY HAND. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS ALSO NO LONGER STAY, ADDITIONAL TREATMENT OR UNEXPECTED BLEEDING TO THE PATIENT REPORTED. IN ADDITION, THE DEVICE WAS INSPECTED PRIOR TO PROCEDURE WITH NO ANOMALIES OBSERVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7963260 ↗
• MalfunctionJun 14, 2018Break; Break

  DURING A LOWER ANTERIOR RESECTION, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE PROBE OF THE SUBJECT DEVICE BROKE OFF AND FELL INTO THE PATIENT. 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 7604143 ↗
• MalfunctionJun 14, 2018Break; Break

  DURING A LOWER ANTERIOR RESECTION, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE PROBE OF THE SUBJECT DEVICE BROKE OFF AND FELL INTO THE PATIENT. 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 7604139 ↗