THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type S TB-0545FCSRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04953170409684), received between Dec 7, 2018 and Jan 27, 2026 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (12 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-1371-2026 · 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-0994-2025 · 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-0109-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL 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 24190417 ↗
• InjuryJan 15, 2026Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087582 ↗
• MalfunctionDec 23, 2025Break; Break

  THE CUSTOMER REPORTED THAT, EARLY ON IN A THERAPEUTIC COLORECTAL RESECTION PROCEDURE, THE PAD OF THEIR THUNDERBEAT DEVICE BECAME LOOSE AFTER SEAL ACTIVATION. THE CUSTOMER FINISHED THE PROCEDURE WITH A REPLACEMENT OLYMPUS DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885048 ↗
• MalfunctionDec 8, 2025Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744238 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THE ULTRASONIC PROBE BROKE IN HALF DURING A THERAPEUTIC GASTRIC BYPASS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425847 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THE THUNDERBEAT FRONT GRIP TYPE S PROBE BROKE DURING USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396216 ↗
• InjuryOct 7, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO ULTRASONIC SURGICAL DEVICE USED DURING A THERAPEUTIC CELIOSCOPY (DISSECTION AROUND A POLYPROPYLENE ELEMENT), HAD THE SCISSOR BROKE (LOST JAWS) IN THE PATIENT'S BELLY DURING ADHESIOLYSIS. AFTER THE SECOND BREAKAGE, A MONOPOLAR HOOK AND ENDOBAG WERE USED TO REMOVE THE BROKEN PIECES. THE FIRST DEVICE WAS USED FOR ABOUT 30 MINUTES AND THE SECOND ONE FOR ABOUT 10 MINUTES. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385176 ↗
• InjuryOct 7, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO ULTRASONIC SURGICAL DEVICES USED DURING A THERAPEUTIC CELIOSCOPY (DISSECTION AROUND A POLYPROPYLENE ELEMENT), HAD THE SCISSOR BROKE (LOST JAWS) IN THE PATIENT'S BELLY DURING ADHESIOLYSIS. AFTER THE SECOND BREAKAGE, A MONOPOLAR HOOK AND ENDOBAG WERE USED TO REMOVE THE BROKEN PIECES. THE FIRST DEVICE WAS USED FOR ABOUT 30 MINUTES AND THE SECOND ONE FOR ABOUT 10 MINUTES. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385140 ↗
• InjurySep 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE THUNDERBEAT JAW BROKE OFF DURING A THERAPEUTIC SLEEVE GASTRECTOMY PROCEDURE AN FELL INTO THE PATIENT CAVITY. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130209 ↗
• MalfunctionJul 22, 2024Break; Break

  DURING THE DEVICE EVALUATION, THE THUNDERBEAT FRONT-ACTUATED GRIP EXHIBITED THE PROBE BROKEN AT ITS DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801796 ↗
• MalfunctionJul 1, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, SHORTLY AFTER STARTING A THERAPEUTIC LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY (LADG) PROCEDURE, THE DEVICE PROBE BROKE OFF INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE OUTPUT OF THE DEVICE WAS DONE ONLY A FEW TIMES WITH THE TISSUE PAD HARDLY WORN WHEN THE EVENT OCCURRED. THE SETTINGS AT THE TIME OF THE EVENT ARE NOT KNOWN. THE USER IS EXPERIENCED IN THE USE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14889432 ↗
• MalfunctionMay 26, 2021Break; Break

  AS REPORTED FOR THIS EVENT, DURING AN UNKNOWN PROCEDURE THE DEVICE TEFLON COATING BROKE OFF INTO THE PATIENT AND WAS RETRIEVED. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886487 ↗
• MalfunctionDec 8, 2020Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING A PROCEDURE OF COELIOSCOPY, THE SUBJECT DEVICE WAS USED. THE DISTAL END OF THE DEVICE BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10964039 ↗
• MalfunctionOct 30, 2019Activation Problem; Activation Problem

  THE MANUFACTURER WAS INFORMED THAT THE DEVICE FAILED DURING A PROCEDURE. THE GENERATOR INDICATED A PROBE DAMAGE ERROR CODE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9255369 ↗
• MalfunctionAug 5, 2019Activation Problem; Activation Problem

  SERVICE CENTER WAS INFORMED THAT DURING A PROCEDURE THE THUNDERBEAT DEVICE FAILED. THE GENERATOR INDICATED VIA AN ERROR CODE THAT THERE WAS PROBE DAMAGE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8861175 ↗
• MalfunctionDec 7, 2018Break; Break

  ON NOVEMBER 12, 2018 OLYMPUS RECEIVED A MEDWATCH, REPORT# (B)(4), WHICH STATES THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE METAL TIP OF THE THUNDERBEAT HANDPIECE BROKE OFF THE IN THE PATIENT. THE TIP WAS RETRIEVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8144691 ↗