THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip TB-0535FCRecalls & reported problems

Summary

The FDA's MAUDE database contains 404 adverse event reports that list this exact device (DI 04953170337574), received between Oct 3, 2016 and May 29, 2026 — classified as 2 deaths, 38 injuries, 364 malfunctions.

The most frequently reported specific device problem is “Break” (200 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-1375-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 404 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Fracture; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S ULTRASONIC KNIFE HEAD CONNECTION POINT FRACTURE AND THE KNIFE BECAME PARTIALLY DETACHED. 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 25337185 ↗
• MalfunctionSep 18, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE EXHIBITED SEVERE PAD WEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092610 ↗
• MalfunctionSep 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE FRONT ACTUATED-GRIP EXHIBITED AN ULTRASONIC SCALPEL HEAD HAD FRACTURED PHENOMENON. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM, INJURY, OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018746 ↗
• MalfunctionJul 18, 2025Failure to Deliver Energy; Peeled/Delaminated; Failure to Deliver Energy; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22549348 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC UNILATERAL NEPHRECTOMY UNDER GENERAL ANESTHESIA DUE TO RENAL SPACE-OCCUPYING LESIONS. THE SURGERY REQUIRED THE USE OF A BIPOLAR HIGH-FREQUENCY ULTRASONIC DUAL-OUTPUT SURGICAL SYSTEM TO COAGULATE AND INCISE TISSUES AND BLOOD VESSELS. WHEN THE SURGEON USED THE THUNDERBEAT DEVICE DURING THE PROCEDURE, THE FRONT GASKET OF THE ULTRASONIC BLADE BROKE. THE ULTRASONIC BLADE WAS IMMEDIATELY REPLACED AND PROCEDURE CONTINUED. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 22300706 ↗
• MalfunctionJun 20, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC UNILATERAL NEPHRECTOMY PROCEDURE WHILE UNDER GENERAL ANESTHESIA DUE TO RENAL SPACE-OCCUPYING LESIONS. THE SURGERY REQUIRED THE USE OF A BIPOLAR HIGH-FREQUENCY ULTRASONIC DUAL-OUTPUT SURGICAL SYSTEM TO COAGULATE AND INCISE TISSUES AND BLOOD VESSELS. WHEN THE SURGEON WAS USING THE THUNDERBEAT DEVICE, THE WHITE GASKET AT THE FRONT END OF THE ULTRASONIC BLADE FELL OFF. THE ULTRASONIC BLADE WAS IMMEDIATELY REPLACED WITH AN ULTRASONIC BLADE AND THE OPERATION CONTINUED. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299970 ↗
• MalfunctionJun 7, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22164181 ↗
• InjuryJun 6, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT APPROXIMATELY ONE HOUR INTO THE LAPAROSCOPIC RIGHT ADRENAL LESION RESECTION PROCEDURE, THE HEAD OF THE ULTRASONIC KNIFE THAT WAS USED TO DISSECT TISSUES SUDDENLY FRACTURED AND THE DEVICE COULD NO LONGER BE USED. THE PROCEDURE WAS SUSPENDED AND THE PROVIDER CLEANED AND EXPLORED TO REMOVE THE FRACTURED KNIFE HEAD COMPLETELY. AFTER A 15-MINUTE DISINFECTION AND CONFIRMATION, A PRODUCT OF THE SAME SPECIFICATION AND MODEL WAS REPLACED TO CONTINUE AND COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160589 ↗
• MalfunctionMay 23, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT¿ S BLADE HEAD FRACTURED DURING A THERAPEUTIC LAPAROSCOPIC PROCEDURE. THE FRACTURED PARTS DID NOT FALL WITHIN THE PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED USING A BACKUP OLYMPUS DEVICE. THERE WAS NO DELAY, PATIENT INJURY, NOR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080601 ↗
• MalfunctionMar 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679516 ↗
• InjuryJan 18, 2025Break; Break

  IT WAS REPORTED "TB-SCISSOR BROKE IN THE PATIENT DURING THE PROCEDURE. ALL THE PIECES HAVE BEEN RECOVERED". THERE WAS NO PATIENT INJURY OR HARM REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186230 ↗
• InjuryDec 27, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THIS SUBJECT DEVICE DID NOT TRIGGER AN ALARM DURING USE. ALTHOUGH THE GENERATOR INVOLVED, IT WAS CONFIRMED THAT THE ISSUE WAS CAUSED BY THE KNIFE HEAD AND NOT RELATED TO THE GENERATOR. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE WHICH RESULTED IN A PROCEDURAL DELAY OF MORE THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. THERE WERE NO REPORTS OF ADVERSE PATIENT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21030621 ↗
• InjuryDec 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPIC UTERINE FIBROID SURGERY, THE THUNDERBEAT PROBE BROKE AND FELL INTO THE ABDOMINAL CAVITY SHORTLY AFTER THE START OF PROCEDURE. THE DEVICE WAS RETRIEVED, AND THE ABDOMINAL CAVITY WAS EXAMINED POST REMOVAL OF THE DEVICE FROM THE PATIENT. FURTHER FOLLOW-UP HAS BEEN CONDUCTED AND PENDING ADDITIONAL INFORMATION REGARDING THE EVENT. NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839562 ↗
• InjuryOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE PROBE OF THE SUBJECT DEVICE FELL INTO THE PATIENT'S BODY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447025 ↗
• InjuryOct 14, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY FOR MULTIPLE UTERINE LEIOMYOMAS, THUNDERBEAT WAS USED FOR TISSUE CUTTING. AFTER USING THE PRODUCT FOR MORE THAN HALF AN HOUR, THE TIP OF THE ULTRASONIC KNIFE FELL OFF AND THIS DEVICE WAS NOT ABLE TO BE USED TO CONTINUE THE PROCEDURE. HENCE THE MEDICAL STAFF ¿IMMEDIATELY¿ REPLACED A NEW DEVICE TO CONTINUE WITH THE SURGERY. THE SURGERY TIME WAS REPORTED TO BE EXTENDED, BUT THE NEW DEVICE WAS ¿IMMEDIATELY¿ REPLACED BY THE STAFF INDICATING THAT THE DELAY IS EXPECTED TO BE MINIMAL. FOLLOW-UP WAS CONDUCTED TO REQUEST INFORMATION IF THE DEVICE FELL INTO THE PATIENT AND IF THE DEVICE WAS REMOVED FROM PATIENT. RESPONSE RECEIVED NOTED THAT THE DEVICE PIECE DID NOT FALL INTO THE BODY. AT THIS TIME, THERE IS NO EVIDENCE THAT A LIFE-THREATENING EVENT OCCURRED, THAT THE PATIENT DEVELOPED PERMANENT DAMAGE OR IMPAIRMENT, OR THAT ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS DONE TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT THAT IS ASSOCIATED WITH THE USE OF AN OLYMPUS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20445834 ↗
• InjuryAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC PROCEDURE, THE PROBE OF THE THUNDERBEAT FELL OFF INTO THE PATIENT'S BODY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035553 ↗
• MalfunctionJul 25, 2024No Display/Image; Material Split, Cut or Torn; No Display/Image; Material Split, Cut or Torn

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED, DUE TO A CUT ON CHARGED COUPLED DEVICE CABLE, AN IMAGE NOISE OCCURS WITH NO IMAGE DURING ANGULATION IN UPWARD/DOWNWARD DIRECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19831801 ↗
• MalfunctionJul 9, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE ULTRASONIC SURGICAL DEVICE PROBE FELL OFF OUTSIDE OF THE PATIENT'S BODY. THE ISSUE OCCURRED DURING A THERAPEUTIC RADICAL PROSTATECTOMY. THERE WERE NO REPORTS OF PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705167 ↗
• InjuryJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RADICAL PROSTATECTOMY, THE PROBE WAS FOUND FALLING INTO THE PATIENT'S ABDOMINAL CAVITY. THE FALLEN PROBE WAS RECOVERED WITH FORCEPS. IT TOOK 1 MINUTE TO RETRIEVE THE PROBE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO INJURY OR HEALTH DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625487 ↗
• InjuryJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC REMOVAL OF THE GALLBLADDER, THE PROBE OF THE THUNDERBEAT FELL OFF INTO THE PATIENT'S BODY. THE DEVICE PIECE FELL AROUND THE LIVER AND WAS RETRIEVED WITH A SNARE. THE RETRIEVAL TIME TOOK ABOUT 30 SECONDS. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511350 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT THE CHIEF SURGEON USED AN ULTRASOUND KNIFE TO COAGULATE AND CUT THE PATIENT'S TISSUE AND BLOOD VESSELS, HOWEVER, THE THUNDERBEAT KNIFE HEAD WAS BROKEN AND UNUSABLE. THE ISSUE OCCURRED DURING THE THERAPEUTIC LAPAROSCOPIC SUBTOTAL GASTRECTOMY WITH GASTROJEJUNOSTOMY. THE PATIENT WAS UNDER GENERAL ANESTHESIA DUE TO GASTRIC CANCER AND PYLORIC OBSTRUCTION. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE, WHICH DELAYED THE PROCEDURE TIME BY ABOUT 5 MINUTES. NO FRAGMENT FELL INTO THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486308 ↗
• InjuryMay 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TISSUE PAD FELL OFF AND INTO THE PATIENT¿S ABDOMINAL CAVITY. THE TISSUE PAD WAS RETRIEVED WITHIN FIVE MINUTES USING FORCEPS. THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THE TIME OF THE EVENT. THE PATIENT¿S OUTCOME WAS REPORTED AS ¿NORMAL.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315200 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE ULTRASONIC SURGICAL DEVICE TISSUE PAD FELL OFF OUTSIDE OF THE PATIENT'S BODY. THE ISSUE OCCURRED DURING A THERAPEUTIC RADICAL RECTAL CANCER RESECTION. THERE WERE NO REPORTS OF PATIENT HARM. USER FINISHED THE CASE WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19306638 ↗
• InjuryMay 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BROKEN DEVICE WAS VERY QUICKLY RETRIEVED WITH FORCEPS. NO ADDITIONAL INTERVENTIONS WERE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250433 ↗
• InjuryApr 12, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THERAPEUTIC RIGHT LAPAROSCOPIC HEMICOLECTOMY PROCEDURE, THE THUNDERBEAT PROBE TIP BROKE AND FELL OFF INSIDE THE PATIENT AND WAS IMMEDIATELY REMOVED AND CHECKED FOR INTEGRITY AND NO RESIDUE WAS LEFT OFF. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAY DURING THE PROCEDURE. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101059 ↗