THUNDERBEAT Open Fine Jaw Type X TB-0009OFX (REF N5768340)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04953170435829), received between Aug 17, 2023 and Nov 23, 2024 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE THUNDERBEAT MALFUNCTIONED, THE TIP OF THE PAD CAME LOOSE AND FLOATED AWAY DURING OUTPUT. THERE WAS NO LOSS INSIDE THE PATIENT. THE ISSUE OCCURRED DURING SEDATION, BEFORE A THERAPEUTIC UNILATERAL NECK DISSECTION, AND WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20766585 ↗
• MalfunctionOct 25, 2024Material Erosion; Material Erosion

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537959 ↗
• MalfunctionOct 17, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472753 ↗
• MalfunctionOct 11, 2024Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427792 ↗
• MalfunctionSep 19, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE THUNDERBEAT'S TISSUE PAD WAS WORN OUT AND AN ERROR U504 OCCURRED. THE ISSUE OCCURRED DURING THE THERAPEUTIC BREAST SURGERY. 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 20260049 ↗
• MalfunctionSep 11, 2024Peeled/Delaminated; Peeled/Delaminated

  DURING, THE DEVICE EVALUATION. THE OPEN FINE JAW EXHIBITED PEELING OF THE TISSUE PAD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195711 ↗
• MalfunctionSep 9, 2024Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169129 ↗
• MalfunctionSep 6, 2024Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158460 ↗
• MalfunctionSep 6, 2024Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158449 ↗
• MalfunctionSep 6, 2024Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158257 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THE ULTRASONIC SURGICAL DEVICE ENTIRE TISSUE PAD BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC OTOLARYNGOLOGY THYROID 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 20127847 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THE ULTRASONIC SURGICAL DEVICE HAD A PROBE TIP THAT BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC CONCHOTOMY PROCEDURE. THE BROKEN PROBE TIP DID NOT FALL INTO THE CUSTOMER'S BODY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO DELAY TO THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030584 ↗
• MalfunctionAug 21, 2024Degraded; Degraded

  DURING THE DEVICE EVALUATION, THE THUNDERBEAT OPEN FINE JAW EXHIBITED A SEVERELY WORN OUT OF THE TISSUE PAD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009912 ↗
• MalfunctionJun 19, 2024Material Separation; Material Separation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE EXHIBITED PARTIAL SEPARATION OF THE TISSUE PAD INSULATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568054 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE ULTRASONIC SURGICAL DEVICE EXHIBITED TISSUE PAD PARTIAL SEPARATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112524 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE ULTRASONIC SURGICAL DEVICE HAD A SEAL CUT ERROR OCCUR AND IT WAS FOUND THAT THE UPPER JAW WAS LOOSE AND SEPARATED FROM THE DEVICE. THE ISSUE OCCURRED DURING A THERAPEUTIC THYROID PROCEDURE. THE PART DID NOT FALL INTO THE PATIENT'S BODY, THERE WAS NO PROCEDURAL DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105972 ↗
• MalfunctionApr 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE ULTRASONIC SURGICAL DEVICE PROBE BROKE DURING THE SURGERY. NOTHING FELL INSIDE THE BODY. THE ISSUE OCCURRED DURING THERAPEUTIC HEAD AND NECK TUMOR DISSECTION. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS IN SEAL AND CUT FUNCTIONAL MODE AT THE TIME OF THE EVENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. THE PROCEDURE WAS COMPLETED NORMALLY WITH NO DELAY USING A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038193 ↗
• MalfunctionMar 15, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE EXHIBITED SEVERE WEAR OF THE TISSUE PAD. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918821 ↗
• MalfunctionMar 14, 2024Degraded; Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE EXHIBITED SEVERELY WORN OF THE TISSUE PAD. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904742 ↗
• MalfunctionMar 4, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED, THE THUNDERBEAT OPEN FINE JAW'S TISSUE PAD KEPT COMING OFF SEVERAL TIMES DURING A THERAPEUTIC THYROID PROCEDURE. THERE WAS NO INTERNAL SHEDDING OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM AND THE INTENDED PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED USING A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826611 ↗
• MalfunctionMar 1, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822164 ↗
• MalfunctionFeb 21, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748393 ↗
• InjuryFeb 15, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THERAPEUTIC THYROIDECTOMY THE TISSUE PAD OF THE THUNDERBEAT OPEN FINE JAW PEELED OFF. THERE WAS NO INTERNAL SHEDDING OF THE DEVICE. A SIMILAR NEW DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THE PROCEDURE WAS PROLONGED BY 1 TO 1.5 HOURS TO REPLACE WITH THE NEW DEVICE. THERE WERE NO HEALTH HAZARDS REPORTED TO THE PATIENT. THE DEVICE WAS INSPECTED AND THERE WERE NO FAULTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18715216 ↗
• InjuryFeb 2, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE THUNDERBEAT PROBE BROKE WHEN ELECTRICITY WAS APPLIED INSIDE THE PATIENT'S BODY DURING A THERAPEUTIC THYROIDECTOMY. THE PARTS FELL INTO PATIENT'S HEAD AND NECK AND WERE RETRIEVED WITH A FORCEPS. THE PROCEDURE WAS COMPLETED BY REPLACING WITH A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636631 ↗
• MalfunctionFeb 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THAT THE THUNDERBEAT OPEN FINE JAW TYPE X HAD THE TISSUE PAD TURNED UP. THE ISSUE WAS FOUND DURING THE THERAPEUTIC PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635896 ↗