THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S TB-0535FCSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,373 adverse event reports that list this exact device (DI 04953170409677), received between Jul 3, 2018 and Sep 17, 2026 — classified as 175 injuries, 1,198 malfunctions.

The most frequently reported specific device problem is “Break” (966 reports).

3 FDA recall records name this device's identifier, 3 still open.

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.

Recalls naming this device

1. Oct 22, 2025Class IIOpen, Classified

   Firm is initiating a removal due to continued reports of adverse events.

   Z-1372-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 25, 2024Class IIOpen, Classified

   The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

   Z-0993-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Sep 12, 2023Class IIOpen, Classified

   Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

   Z-0108-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,373 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Detachment of Device or Device Component

  The customer returned the Thunderbeat surgical instrument to the service center for a separate issue. During Olympus¿ device analysis it was indicated that the Thunderbeat surgical instrument's tissue grasping insulation pad was split and detached. There were no reports of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805862 ↗
• MalfunctionJun 23, 2026Fracture

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE PROBE AT THE PROXIMAL TIP OF THE THUNDERBEAT DEVICE BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25598286 ↗
• MalfunctionJun 1, 2026Material Discolored

  THE CUSTOMER RETURNED THE FRONT-ACTUATED GRIP TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE EVALUATION INDICATES THAT A TISSUE PAD CHAR MARK WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354636 ↗
• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT PROBE TIP WAS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348677 ↗
• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT PROBE WAS DETACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348596 ↗
• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT PROBE WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348473 ↗
• MalfunctionMay 29, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE TEFLON PAD WAS SEVERELY WORN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340348 ↗
• MalfunctionMay 29, 2026Peeled/Delaminated; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25339562 ↗
• MalfunctionMay 29, 2026Material Fragmentation; Peeled/Delaminated

  IT WAS OBSERVED DURING THE EVALUATION THAT THE THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S EXHIBITED THAT THE TEFLON PAD WAS WORN AT THE MID SECTION, AND SIGNS OF THERMAL DAMAGE WERE NOTED ON THE PROBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25339348 ↗
• MalfunctionMay 29, 2026Material Separation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND THE PAD IS SEPARATED FROM THE JAW EXPOSING METAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25339192 ↗
• MalfunctionMay 29, 2026Break

  IT WAS OBSERVED DURING THE EVALUATION THAT THE THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S EXHIBITED THAT THE DEVICE HAS A BROKEN PROBE THAT WAS NOT RETURNED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25339069 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE HAD BROKEN PROBE THAT WAS RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25338278 ↗
• MalfunctionMay 29, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND IT IS SEVERELY WORN AND EXPOSING METAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337729 ↗
• MalfunctionMay 29, 2026Fracture; Detachment of Device or Device Component; Naturally Worn

  THE CUSTOMER RETURNED THE FRONT-ACTUATED GRIP TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE EVALUATION INDICATED THAT PROBE WAS BROKEN AT 16.16 MM FROM ITS DISTAL END AND THE TISSUE PAD IN THE GRASPING SECTION WAS WORN AWAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337326 ↗
• MalfunctionMay 29, 2026Fracture

  IT WAS REPORTED THE THUNDERBEAT PROBE TIP FRACTURED DURING A THERAPEUTIC HYSTERECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE WAS A DELAY TO THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25334578 ↗
• MalfunctionMay 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THERAPEUTIC HYSTERECTOMY PROCEDURE THE THUNDERBEAT'S PROBE TIP BROKE OFF. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279643 ↗
• MalfunctionMay 22, 2026Fracture; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FRONT-ACTUATED GRIP EXHIBITED THE PROBE WAS BROKEN AT 14.64 MM FROM ITS DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262709 ↗
• MalfunctionMay 22, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THE ULTRASONIC SURGICAL DEVICE PROBE BROKE OFF DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE; THE BROKEN TIP WAS RETRIEVED OUTSIDE OF THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256271 ↗
• MalfunctionMay 21, 2026Detachment of Device or Device Component

  IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE THUNDERBEAT SURGICAL INSTRUMENT'S GRASPING PART INSULATION PAD WAS DETACHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25250177 ↗
• MalfunctionMay 21, 2026Detachment of Device or Device Component

  IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE THUNDERBEAT GRASPING PART INSULATION PAD WAS MISSING AND THE METAL WAS EXPOSED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249933 ↗
• MalfunctionMay 21, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT PROBE WAS COMPLETELY BROKEN OFF FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243094 ↗
• MalfunctionMay 21, 2026Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT TEFLON PAD WAS SEVERELY WORN AND APPEARED TO BE MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242950 ↗
• MalfunctionMay 21, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT PROBE WAS DETACHED FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242895 ↗
• MalfunctionMay 21, 2026Material Integrity Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT TEFLON PAD WAS MISSING FROM THE JAW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242768 ↗
• MalfunctionMay 21, 2026Fracture

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT PROBE WAS DETACHED AND NOT RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242339 ↗