THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S TB-0520FCS (UDI 04953170383571)Recalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 04953170383571), received between Aug 17, 2018 and May 29, 2026 — classified as 30 injuries, 149 malfunctions.

The most frequently reported specific device problem is “Break” (96 reports).

2 FDA recall records name this device's identifier, 2 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-1373-2026 · 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-1001-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Improper or Incorrect Procedure or Method

  THE CUSTOMER RETURNED THE THUNDERBEAT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE OLYMPUS SERVICE REPAIR TECHNICIAN INDICATED THAT A USE OF EXPIRED PRODUCT WAS FOUND. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331122 ↗
• MalfunctionFeb 27, 2026Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474472 ↗
• MalfunctionFeb 5, 2026Break; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THE THUNDERBEAT'S PROBE BROKE IMMEDIATELY AFTER IT WAS ACTIVATED DURING UNSPECIFIED USE. ADDITIONAL DETAILS WERE REQUESTED FROM THE CUSTOMER BUT THE INFORMATION WAS UNKNOWN. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269295 ↗
• InjuryJan 16, 2026Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIGESTIVE LAPAROTOMY PROCEDURE, THE TIP OF THE ULTRASONIC SURGICAL DEVICE BROKE AND A FRAGMENT FELL INTO THE PATIENT¿S ABDOMINAL CAVITY. THE FRAGMENT WAS RETRIEVED WITH DISSECTING FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101270 ↗
• MalfunctionJan 2, 2026Break

  IT WAS REPORTED THAT THE THUNDERBEAT OPEN EXTENDED JAW BROKE DURING NORMAL USE. THE BURNING PART OF THE JAW TIP HAS PARTIALLY COME OFF. THERE WERE NO REPORTS OF PATIENTS¿ HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952211 ↗
• MalfunctionDec 29, 2025Fracture; Fracture

  IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S TIP WAS BROKEN OFF DURING A THERAPEUTIC PANCREATECTOMY. IT WAS NOT SPECIFIED WHERE FRAGMENTS FELL. THERE WAS NOT REPORTED PATIENT INJURY ATTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919185 ↗
• MalfunctionDec 18, 2025Break; Break

  THE CUSTOMER REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE TIP OF THE THUNDERBEAT DEVICE BROKE DURING THE OPERATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846673 ↗
• InjuryNov 3, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE ULTRASONIC SURGICAL DEVICE DETACHED AND FELL INTO THE PATIENT'S INTESTINAL LOOPS. THE TIP WAS RETRIEVED BY THE SURGEON USING VASCULAR FORCEPS. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450605 ↗
• MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S GRASPING SECTION CAME OFF. THE EVENT OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433332 ↗
• MalfunctionAug 19, 2025Thermal Decomposition of Device; Separation Problem; Thermal Decomposition of Device; Separation Problem

  NO ADDITIONAL CUSTOMER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842548 ↗
• MalfunctionAug 19, 2025Thermal Decomposition of Device; Peeled/Delaminated; Separation Problem; Thermal Decomposition of Device; Peeled/Delaminated; Separation Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842482 ↗
• MalfunctionAug 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S GRASPING PAD WAS SEPARATING AND THE DEVICE STARTED SMOKING DURING THE MIDDLE OF A THERAPEUTIC OPEN PYLORUS PRESERVING PANCREATODUODENECTOMY PROCEDURE, WHICH WAS COMPLETED WITH A SIMILAR DEVICE AFTER A <10 MINUTE DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815883 ↗
• MalfunctionJul 22, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22567024 ↗
• InjuryJun 26, 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 22337151 ↗
• InjuryJun 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC, OPEN MULTIPLE LIVER LESION RESECTION PROCEDURE, UNDER GENERAL ANESTHESIA, THUNDERBEAT PROBE PORTION OF THE PROBE BROKE OFF INTO THE UPPER RIGHT QUADRANT OF THE ABDOMEN, UNDER THE RIB CAGE. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED USING FORCEPS, AND NO UNPLANNED DIAGNOSTIC IMAGING WAS REQUIRED TO LOCATE OR CONFIRM REMOVAL OF THE FRAGMENT. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. A 15-MINUTE DELAY IN THE PROCEDURE WAS REPORTED. NO PATIENT INJURY OR HARM RESULTED FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237798 ↗
• MalfunctionJun 11, 2025Naturally Worn; Naturally Worn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED WEAR OF THE TISSUE PAD IN THE GRASPING SECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184857 ↗
• MalfunctionApr 18, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866098 ↗
• MalfunctionFeb 25, 2025Melted; Melted

  IT WAS REPORTED THE THUNDERBEAT EXPERIENCED THE TEFLON MELTED AND THERE WAS NO ALARM. THE ISSUE OCCURRED DURING THERAPEUTIC HYSTERECTOMY AND DISSECTION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAYS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463390 ↗
• MalfunctionNov 11, 2024Fracture; Fracture

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE ULTRASONIC SURGICAL DEVICE EXHIBITED THE PROBE WAS BROKEN AT 9.4, MM FROM ITS DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20659551 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED, THE ULTRASONIC SURGICAL DEVICE TIP BROKE OFF. WHEN TRYING TO REMOVE A FOREIGN MATERIAL. THE ISSUE OCCURRED, DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY. 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 20659326 ↗
• InjuryOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE THUNDERBEAT CAME OFF INSIDE THE PATIENT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THIS OCCURRED TWICE WITH TWO SEPARATE THUNDERBEATS. BOTH TIPS WERE RECOVERED COMPLETELY FROM THE PATIENT. DUE TO THE ISSUE, THERE WAS AN APPROXIMATE 20 MINUTE DELAY WHILE UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY, WITHOUT HARM TO THE PATIENT, WITH ANOTHER THUNDERBEAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465022 ↗
• InjuryOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE THUNDERBEAT CAME OFF INSIDE THE PATIENT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THIS OCCURRED TWICE WITH TWO SEPARATE THUNDERBEATS. BOTH TIPS WERE RECOVERED COMPLETELY FROM THE PATIENT. DUE TO THE ISSUE, THERE WAS AN APPROXIMATE 20 MINUTE DELAY WHILE UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY, WITHOUT HARM TO THE PATIENT, WITH ANOTHER THUNDERBEAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464944 ↗
• MalfunctionSep 30, 2024Thermal Decomposition of Device; Material Separation; Thermal Decomposition of Device; Material Separation

  IT WAS REPORTED, THE ULTRASONIC SURGICAL INSTRUMENT TEFLON PAD SLIGHTLY MELTED AND SEPARATED. THE ISSUE OCCURRED DURING A THERAPEUTIC UNSPECIFIED EMERGENCY PROCEDURE. THERE WAS A 5 MINUTE DELAY TO CHANGE THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334707 ↗
• MalfunctionSep 30, 2024Thermal Decomposition of Device; Material Separation; Thermal Decomposition of Device; Material Separation

  IT WAS REPORTED, THE ULTRASONIC SURGICAL INSTRUMENT TEFLON PAD SLIGHTLY MELTED AND SEPARATED. THE ISSUE OCCURRED DURING A THERAPEUTIC UNSPECIFIED EMERGENCY PROCEDURE. THERE WAS A 5 MINUTE DELAY TO CHANGE THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334652 ↗
• MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE ULTRASONIC SURGICAL THUNDERBEAT PROBE DETACHED. THE ISSUE OCCURRED DURING THE MIDDLE OF AN UNSPECIFIED THERAPEUTIC EMERGENCY PROCEDURE. THERE WAS A FIVE MINUTE DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20325505 ↗