THUNDERBEAT Open Fine Jaw Type X TB-0009OFX (UDI 04953170394584)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04953170394584), received between Sep 26, 2022 and Aug 6, 2026 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158801 ↗
• MalfunctionJun 3, 2026Material Fragmentation

  THE CUSTOMER RETURNED THE THUNDERBEAT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE OLYMPUS SERVICE TECHNICIAN INDICATED THAT THE TISSUE PAD WAS WORN OUT, AND A PORTION OF IT WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374752 ↗
• MalfunctionMay 29, 2026Peeled/Delaminated

  THE CUSTOMER RETURNED THE THUNDERBEAT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING OLYMPUS¿ DEVICE ANALYSIS IT WAS INDICATED THAT THE THUNDERBEAT SURGICAL INSTRUMENT'S TISSUE PAD PEELED OFF . THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340775 ↗
• MalfunctionApr 29, 2026Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT HAD PEELING OF THE TISSUE PAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034053 ↗
• MalfunctionJan 23, 2026Crack; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE OPEN FINE JAW TYPE X EXHIBITED PEELING OF THE TISSUE PAD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160232 ↗
• MalfunctionJan 5, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969443 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SUBJECT DEVICE HANDPIECE DISASSEMBLED WHILE IN USE DUE TO LOOSENING. THE ISSUE OCCURRED DURING A THERAPEUTIC THYROIDECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877784 ↗
• InjuryDec 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829575 ↗
• MalfunctionNov 17, 2025Naturally Worn; Naturally Worn

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE OPEN FINE JAW TYPE X EXHIBITED TISSUE PAD WAS WORN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567765 ↗
• MalfunctionNov 14, 2025Naturally Worn; Naturally Worn

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE OPEN FINE JAW TYPE X EXHIBITED THE TISSUE PAD WAS UNEVENLY WORN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23563422 ↗
• MalfunctionOct 29, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT EXHIBITED PEELING AWAY OF THE TISSUE PAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417515 ↗
• MalfunctionAug 29, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL CUSTOMER INFO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929143 ↗
• MalfunctionAug 28, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE TISSUE PAD WAS PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916112 ↗
• MalfunctionAug 18, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT 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 22833884 ↗
• MalfunctionApr 1, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL INSTRUMENT EXHIBITED PEELING OF THE TISSUE PAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21742725 ↗
• MalfunctionMar 28, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TISSUE PAD WAS WORN OUT, AND IT WAS PARTIALLY PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721477 ↗
• MalfunctionMar 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED TORN TEFLON. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504786 ↗
• MalfunctionJan 7, 2025Melted; Melted

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21097014 ↗
• MalfunctionJan 6, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE INVESTIGATION FROM AN IMAGE PROVIDED BY THE CUSTOMER, THE THUNDERBEAT EXHIBITED A PEELING PAD. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085975 ↗
• MalfunctionMar 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE ULTRASONIC SURGICAL DEVICE TISSUE PAD FELL OFF AND IT IS UNKNOWN WHETHER IT IS OUTSIDE OR INSIDE THE BODY. THE ISSUE OCCURRED DURING HEPATOTOMY THERAPEUTIC PROCEDURE. THE CUSTOMER IMMEDIATELY COLLECTED IT AND REPLACED WITH ANOTHER ONE, AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937590 ↗
• InjurySep 5, 2023Peeled/Delaminated; Difficult to Remove; Detachment of Device or Device Component; Peeled/Delaminated; Difficult to Remove; Detachment of Device or Device Component

  DURING A LARYNGECTOMY WITH LARYNGEAL TUMOR AND NECK DISSECTION, THE PROBE TIP OF THE THUNDERBEAT OPEN FINE JAW TYPE X BROKE AND FELL OFF WHEN THE NECK DISSECTION WAS COMPLETED AND CONNECTED TO THE ESOPHAGUS DURING THE OPERATION. THE PROBE WAS IMMEDIATELY COLLECTED WITH FORCEPS AND THERE WERE NO REMNANTS. THE EVENT OCCURRED SIXTEEN HOURS AFTER THE START OF THE PROCEDURE WHICH TAKES ABOUT TWENTY-FOUR HOURS. ADDITIONALLY, THE TISSUE PAD WAS PEELING OFF AND WAS DAMAGED BY METAL-TO-METAL CONTACT. AT THE END OF THE PROCEDURE, THE THUNDERBEAT SCISSORS COULD NOT BE REMOVED FROM THE THUNDERBEAT TRANSDUCER AND THE USER INTENTIONALLY BROKE IT APART WITH AN ULTRASONIC SCALPEL AND REMOVED IT. THE PROCEDURE WAS COMPLETED WITH A MARIS BIPOLAR WHICH WAS ORIGINALLY USED IN THE SURGERY, AND WITHOUT CHANGING THE EQUIPMENT. THERE WAS NO PROCEDURE EXTENSION, NO DELAY IN SURGERY AND NO ADDITIONAL ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ANOMALIES AND THE CONNECTION TO THE GENERATOR WAS VERIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684935 ↗
• MalfunctionAug 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE DEVICE EVALUATION, IT WAS CONFIRMED THAT THE BROKE WAS BROKEN. THIS REPORT IS BEING SUBMITTED FOR THE BROKEN PROBE. ADDITIONALLY, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION WHICH CONFIRMED THAT THE DAMAGED DEVICE DID NOT FALL INTO THE PATIENT'S BODY OR ON THE GROUND. THE CUSTOMER HAD TROUBLE SEPARATING THE DEVICE FROM THE HANDPIECE. THE DAMAGED TRANSDUCER EVENT OCCURRED AFTER THE PROCEDURE DURING CLEAN UP. THERE WAS NO IMPACT TO THE PATIENT OR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510519 ↗
• MalfunctionJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE TISSUE PAD OF THE THUNDERBEAT OPEN FINE JAW TYPE X WAS DAMAGED. THE ISSUE WAS FOUND ONE TO TWO HOURS AFTER STARTING A MALIGNANT TONGUE SURGERY. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND INSULATION PAD PEELING. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054447 ↗
• MalfunctionMar 27, 2023Material Separation; Material Separation

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, AT THE BEGINNING OF AN OPERATION AN ERROR OF ULTRASONIC AMPLITUDE ABNORMALITY (U509) OCCURRED WITH THE THUNDERBEAT. THE DEVICE BECAME UNUSABLE, AND THE THERAPEUTIC HEAD AND NECK SURGERY WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS A DELAY FOR DEVICE REPLACEMENT, BUT NO ADDITIONAL ANESTHESIA WAS NECESSARY FOR THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING INCOMING INSPECTION, THERE WAS SEVERE WEAR OF TISSUE PAD. THIS MEDWATCH IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618922 ↗
• MalfunctionMar 7, 2023Material Separation; Material Separation

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, 30 MINUTES INTO A THYROIDECTOMY IN LAPAROTOMY PROCEDURE, THE TISSUE PAD OF THE DEVICE BEGAN TO PEEL OFF. PROCEDURE WAS COMPLETED WITH A NEW DEVICE OF THE SAME MODEL NUMBER WITHOUT ANY DELAY. THE PATIENT DID NOT NEED ADDITIONAL ANESTHESIA. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. TOTAL OPERATING TIME OF THE PROCEDURE IS WITHIN TWO HOURS. THE INTELLIGENT TISSUE MONITORING (ITM) SETTING WAS OFF DURING THE PROCEDURE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED. THE CONNECTIONS TO THE GENERATOR WERE CHECKED. THE TRANSDUCER CORDS AND OTHER MEDICAL DEVICE CORDS WERE NOT BUNDLED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496467 ↗