THUNDERBEAT 5 mm, 35 cm, Pistol Grip TB-0535PCRecalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 04953170308659), received between May 14, 2018 and Dec 4, 2025 — classified as 12 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Break” (43 reports).

1 FDA recall record name this device's identifier, 1 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-1378-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE EXHIBITED THE GRASPING SECTION (JAW) BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23717338 ↗
• MalfunctionAug 1, 2025Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE THUNDERBEAT'S INSULATION PAD WAS SEVERELY WORN: IT WAS SPLIT AND PEELING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22684356 ↗
• MalfunctionAug 1, 2025Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE THUNDERBEAT'S INSULATION PAD WAS SEVERELY WORN, SPLIT, AND PEELING OFF OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22684192 ↗
• MalfunctionJun 14, 2025Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S PROBE BECAME LOOSE BUT THEY WERE ABLE TO REMOVE IT FROM THE PATIENT BEFORE THE PROBE COULD FALL OFF INTO THE PATIENT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED USING A SECOND THUNDERBEAT. THE MALFUNCTION CAUSED A DELAY TO THE PROCEDURE OF LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 22208233 ↗
• InjuryApr 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868197 ↗
• InjuryApr 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE SUBJECT DEVICE BROKE OFF AND WAS RETRIEVED FROM THE PATIENT DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868180 ↗
• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED THE THUNDERBEAT BROKE DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736432 ↗
• MalfunctionApr 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT TEFLON PAD OF THE ULTRASONIC SURGICAL DEVICE WAS DETACHED AND FAILED UPON INITIAL CLINICAL USE. THERE WERE NO ERROR CODES NOTED BY THE CUSTOMER. THE ISSUE OCCURRED DURING UNSPECIFIED THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE WITH A MINIMAL DELAY AND THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119126 ↗
• MalfunctionApr 4, 2024Break; Break

  IT WAS REPORTED, THE ULTRASONIC PROBE OF THE ULTRASONIC SURGICAL DEVICE WAS BROKEN. THE ISSUE WAS FOUND DURING INITIAL CLINICAL USE FOR AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048172 ↗
• InjuryMar 21, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC HYSTERECTOMY THE PROBE FELL OFF INTO THE PATIENTS ABDOMINAL CAVITY. THE PROBE WAS RETRIEVED WITH ANOTHER INSTRUMENT AND THERE WAS NO EFFECT TO THE PATIENT'S HEALTH. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956609 ↗
• InjuryFeb 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE THUNDERBEAT PROBE TIP BROKE OFF AND FELL INSIDE THE PATIENT DURING A THERAPEUTIC PROCEDURE. THE USER WAS ABLE TO RETRIEVE THE BROKEN PIECE AND THE PROCEDURE WAS COMPLETED. NO REPORTS OF PATIENT HARM. THE PROCEDURAL DETAILS AND OUTCOME OF THE PROCEDURE WERE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699296 ↗
• InjuryFeb 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE THUNDERBEAT PROBE TIP BROKE OFF AND FELL INSIDE THE PATIENT DURING A THERAPEUTIC PROCEDURE. THE USER WAS ABLE TO RETRIEVE THE BROKEN PIECE AND THE PROCEDURE WAS COMPLETED. NO REPORTS OF PATIENT HARM. THE PROCEDURAL DETAILS AND OUTCOME OF THE PROCEDURE WERE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699279 ↗
• InjuryJan 30, 2024Break; Break

  IT WAS REPORTED, THE JAW FELL OFF THE ULTRASONIC SURGICAL DEVICE ABOUT 15 MINUTES INTO THE HYSTERECTOMY PROCEDURE AND IT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM. NEW INFORMATION FROM THE CUSTOMER CHANGED THE INITIAL REPORTED EVENT FROM A REPORTABLE MALFUNCTION TO A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610357 ↗
• MalfunctionDec 30, 2023Break; Break

  IT WAS REPORTED THAT THE ULTRASONIC SURGICAL DEVICE HAD AN OUT-OF-BOX FAILURE. THE UNIT'S TIP BROKE OFF DURING A THERAPEUTIC PROCEDURE, AND THE CUSTOMER WAS ABLE TO RETRIEVE IT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422709 ↗
• MalfunctionDec 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, DURING THE THERAPEUTIC PROCEDURE, THE THUNDERBEAT TEFLON PAD DETACHED. THERE WAS A MINIMAL DELAY WHILE A SECOND THUNDERBEAT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO ERROR CODES NOTED AND THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. NO IMPACT TO THE PATIENT OR THE OUTCOME OF THE PROCEDURE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384209 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE ULTRASONIC SURGICAL DEVICE'S TISSUE PAD PARTIALLY CAME OFF DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, BUT IT DID NOT FALL OFF. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248382 ↗
• InjuryNov 29, 2023Break; Break

  IT WAS REPORTED THAT THE JAW FELL OFF THE ULTRASONIC SURGICAL DEVICE PRIOR TO THE BEGINNING THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18225597 ↗
• MalfunctionNov 8, 2023Material Separation; Material Separation

  A CUSTOMER REPORTED TO OLYMPUS, THE THUNDERBEAT JAW MELTED (TISSUE PAD) WHILE ACTIVATING THE DEVICE. THE EVENT OCCURRED AT THE BEGINNING OF LAPAROSCOPIC NEPHRECTOMY. THERE WAS A PROCEDURAL DELAY OF ABOUT 10 MINUTES WHILE CHANGING TO A NEW DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092959 ↗
• InjuryOct 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE ACTIVE PROBE ON THE THUNRDERBEAT FELL OFF DURING THE LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE. THE PROBE WAS RETRIEVED QUICKLY AND THE PATIENT WAS NOT HARMED. THERE WAS NO PROCEDURAL DELAY AND ANOTHER HANDPIECE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION NEEDED AS A RESULT OF THE ISSUE AND THE OUTCOME OF THE PROCEDURE WAS NOT AFFECTED. THE DEVICE WAS INSPECTED BEFORE USE AND APPEARED TO BE NORMAL. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887738 ↗
• MalfunctionSep 8, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP HAND PIECE TIP BROKE DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17716445 ↗
• InjuryJun 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS CLARIFIED THAT IT WAS THE TISSUE PAD OF THE GRASPING SECTION THAT HAD DETACHED. THIS REQUIRED A COMPONENT CODE CORRECTION TO PAD IN F10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114025 ↗
• InjuryJun 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS CLARIFIED THAT IT WAS THE TISSUE PAD OF THE GRASPING SECTION THAT HAD DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113743 ↗
• MalfunctionMay 3, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE TEFLON PAD FELL OFF DURING A PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864778 ↗
• MalfunctionMar 9, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP WHITE PART CAME OFF AT THE BEGINNING OF THE THERAPEUTIC PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518759 ↗
• MalfunctionFeb 2, 2023Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING AN UNKNOWN PROCEDURE THE DEVICE PROBE BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16282418 ↗