THUNDERBEAT Open Extended Jaw TB-0920OE (UDI 04953170343315)Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 04953170343315), received between Oct 5, 2016 and May 20, 2026 — classified as 8 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (49 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Material Fragmentation

  IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S PROBE HAD BROKEN EDGES THAT FELL WITHIN THE PATIENT ANATOMY DURING AN ABDOMINAL PERINCOL RESECTION FOR RECTAL CANER. THE DEVICE FRAGMENT WAS RETRIEVED WITH FORCEPS AND RESULTED IN A DELAY TO THE PROCEDURE OF LESS THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH A BACK-UP OLYMPUS DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234752 ↗
• MalfunctionJan 27, 2026Naturally Worn

  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 24189533 ↗
• MalfunctionNov 4, 2025Device Reprocessing Problem; Material Separation; Detachment of Device or Device Component; Device Reprocessing Problem; Material Separation; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE TEFLON PAD WAS DAMAGED AND HAD A MISSING PORTION WHICH WAS EXPOSING THE METAL JAW. THE DISTAL END HAD INDICATIONS OF DRIED RESIDUE ON THE JAW AND PROBES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472552 ↗
• MalfunctionSep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC DEVICE EXHIBITED THAT THE TISSUE PAD IS SPLIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23102680 ↗
• InjuryJan 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN LIVER SURGERY UNDER SEDATION, THE THUNDERBEAT'S PROBE BROKE AND APPROXIMATELY 1CM GOT STUCK IN THE LIVER. IT WAS RETRIEVED WITH NO DAMAGE TO THE SURROUNDING TISSUE AND THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21119410 ↗
• InjurySep 17, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE ULTRASONIC SURGICAL DEVICE PROBE BROKE OFF AND FELL INTO THE PATIENT CAVITY DURING A THERAPEUTIC LAPAROSCOPIC OOPHORECTOMY PROCEDURE. THERE WAS A TWO MINUTE DELAY TO RETRIEVE THE PART WITH GRASPING FORCEPS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241739 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE JAW PROBE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223339 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THE ULTRASONIC SURGICAL DEVICE BLADE BROKE OFF IN THE ABDOMINAL AREA. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT BODY, RESULTING IN A SLIGHT DELAY. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOUROLOGICAL PROCEDURE. 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 19983294 ↗
• MalfunctionJul 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, WHILE USING THE ULTRASONIC SURGICAL DEVICE, AFTER 2-3 MINUTES OF INTERVENTION ONE OF THE TWO PROBES OF THE TB-SCISSOR BROKE (AND DETACHED FROM THE DEVICE). THE BROKEN PIECE FELL OUTSIDE THE PATIENT'S BODY. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THE PATIENT DID NOT REQUIRE ADDITIONAL ANESTHESIA, THERE WAS NO PROLONGED HOSPITALIZATION AND NO OTHER INTERVENTION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691676 ↗
• MalfunctionJun 12, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE ULTRASONIC SURGICAL DEVICE JAW BROKE OFF. NOTHING FELL INTO THE PATIENT CAVITY. THE ISSUE OCCURRED DURING AN THERAPEUTIC DIXON (LOW ANTERIOR RESECTION WITH PRESERVATION OF THE ANAL SPHINCTER) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520971 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE EXTENDED JAW HAD A BROKEN PROBE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049587 ↗
• InjuryFeb 16, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN USING A THUNDERBEAT OPEN EXTENDED JAW, IN AN UNKNOWN PROCEDURE A BRANCH OF THE JAW BROKE OFF AND WAS REMOVED WITH THE AID OF X-RAYS. THERE WAS NO HEATH DAMAGE REPORTED AS A RESULT. UPON FOLLOW-UP, NO OTHER PROCEDURAL OR PATIENT OUTCOME DETAILS ARE AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18724374 ↗
• MalfunctionJan 16, 2024Fracture; Fracture

  A CUSTOMER REPORTED TO OLYMPUS THE BREAKAGE OF THE TIP OF AN ULTRASOUND DEVICE (THUNDERBEAT). THE EVENT OCCURRED DURING A THERAPEUTIC LIVER RESECTION. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519039 ↗
• InjuryJan 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN OPEN THERAPEUTIC RADICAL PROSTATECTOMY PROCEDURE, THE THUNDERBEAT JAW BROKE OFF INSIDE A PATIENT. A NEW DEVICE WAS OPENED, AND PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. NO REPORT OF ANY ADDITIONAL MEDICAL INTERVENTION/TREATMENT REQUIRED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH A 10-MINUTE DELAY. NO PATIENT INJURY REPORTED. THE DEVICE WAS INSPECTED BEFORE USE. DETAILS OF THE PATIENT'S CURRENT CONDITION, DEVICE RETRIEVAL, MEDICAL INTERVENTION WERE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18457431 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "A CASE OF RUPTURED GASTRODUODENAL ARTERY PSEUDOANEURYSM 2 MONTHS AFTER GASTRECTOMY". SUMMARY: THE PATIENT IS AN 83-YEAR-OLD FEMALE. AN OPEN DISTAL GASTRECTOMY (D2 DISSECTION, BILLROTH I RECONSTRUCTION) WAS PERFORMED FOR GASTRIC CANCER, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE 15TH POSTOPERATIVE DAY WITHOUT ANY COMPLICATIONS. THE PATIENT WAS DIAGNOSED WITH PT2 (MP) N3BMO, PSTAGE IIIB, AND WAS TREATED WITH POSTOPERATIVE ADJUVANT CHEMOTHERAPY USING TS-1 ALONE. ON THE 65TH POSTOPERATIVE DAY, THE PATIENT SUDDENLY DEVELOPED HEMATEMESIS AND MELENA, AND CONTRAST-ENHANCED CT REVEALED BLEEDING FROM A PSEUDOANEURYSM IN THE GASTRODUODENAL ARTERY, SO ARTERIAL EMBOLIZATION WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 30 DAYS AFTER EMBOLIZATION. BLEEDING DUE TO RUPTURE OF A PSEUDOANEURYSM AFTER GASTRECTOMY IS RARE, AND MOST CASES OCCUR SECONDARY TO SUTURE FAILURE OR PANCREATIC FLUID LEAKAGE WITHIN ONE MONTH AFTER SURGERY. ON THE OTHER HAND, THERE ARE ALSO REPORTS OF ARTERIAL DAMAGE CAUSED BY THE HEAT GENERATED BY DEVICES SUCH AS ULTRASONIC COAGULATION AND CUTTING DEVICES, RESULTING IN THE FORMATION OF

  Patient problems: Hematemesis; Hemorrhage/Blood Loss/Bleeding; Melena; Pseudoaneurysm

  MAUDE report 18355868 ↗
• InjuryOct 11, 2023Excessive Heating; Excessive Heating

  THE PADDLE REFERS TO THE PROBE AND GRASP. IT IS UNCLEAR WHICH PART OF THE SHAFT TOUCHED THE PATIENT. THE ENTIRE SHAFT WAS HOT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 17913948 ↗
• MalfunctionOct 5, 2023Material Separation; Material Separation

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING A PROCEDURE, THE THUNDERBEAT OPEN EXTENDED JAW TISSUE PAD CAME OFF. THERE WAS NO SHEDDING INSIDE OF THE PATIENT¿S BODY. THE THERAPEUTIC GASTRECTOMY WAS COMPLETED WITHOUT DELAY, USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF ADDITIONAL ANESTHESIA OR PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17883127 ↗
• MalfunctionJun 23, 2023Material Separation; Material Separation

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING A THERAPEUTIC LIVER RESECTION AN ERROR OCCURRED DURING OUTPUT WITH THE FIRST THUNDERBEAT OPEN EXTENDED JAW AND OUTPUT COULD NOT BE PERFORMED. THE SUBJECT DEVICE WAS SWITCHED TO ANOTHER THUNDERBEAT (TB-0520FCS), BUT THE SAME PHENOMENON OCCURRED. THE PROCEDURE WAS COMPLETED AFTER SWITCHING TO A THIRD THUNDERBEAT (TB-0520FCS). THERE WAS NO REPORT OF A PROCEDURAL DELAY, ADDITIONAL ANESTHESIA OR PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: SEVERE PAD WEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195783 ↗
• InjuryMay 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED TO OLYMPUS THAT DURING AN HYSTERECTOMY, ONE OF TWO JAWS BROKE OFF IN THE PATIENT. THE SURGEON USED ANOTHER SCISSOR TO RETRIEVE THE MISSING PIECE AND COMPLETE THE PROCEDURE. THERE WAS A 20 MINUTE DELAY REPORTED AND NO PATIENT INJURY CONFIRMED. THIS REPORT IS BEING SUBMITTED FOR THE EVENT OF ONE OF TWO JAW BREAKING OFF IN THE PATIENT, REQUIRING A MEDICAL INTERVENTION OF THE SURGEON NEEDING TO USE A DIFFERENT DEVICE TO RETRIEVE THE BROKEN PIECE FROM INSIDE THE PATIENT. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857444 ↗
• InjuryApr 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT DURING OPEN OESOPHAGECTOMY USING THIS ULTRASONIC SURGICAL DEVICE, A CIRCUIT ERROR WAS OBSERVED HOWEVER, THE DEVICE WAS STILL WORKING FINE. WHEN THE USER WAS GRASPING A TISSUE, ONE OF THE PROBE TIPS FELL TO THE ABDOMINAL CAVITY. THE PROBE WAS RETRIEVED WITH NON-TOOTHED FORCEPS. THE RETRIEVED PROBE WAS CHECKED AND IT WAS ALL INTACT AND COMPLETELY REMOVED FROM PATIENT'S CAVITY. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791805 ↗
• MalfunctionMar 2, 2023Material Separation; Material Separation

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE DEVICE TEFLON PAD WAS DETACHED. THERE IS NO REPORTED HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16465953 ↗
• MalfunctionJul 20, 2022Break; Break

  IT WAS REPORTED DURING A ROBOTIC TOTAL PELVIC EXENTERATION (THERAPEUTIC PROCEDURE), WHEN MAKING THE CUT THE TIP HAD UNEXPECTEDLY BROKEN OFF AND FELL OFF. PER THE REPORT, THIS CAUSED A SHORT DELAY (ALTHOUGH NOT CLINICALLY RELEVANT) TO RETRIEVED THE BROKEN PIECE WITH ANOTHER INSTRUMENT. ACCORDING TO THE REPORTER, THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ISSUES NOTED DURING INSPECTION. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO ADVERSE IMPACT REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15069084 ↗
• MalfunctionFeb 17, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC MASTECTOMY PROCEDURE THE GENERATOR KEPT GIVING ALARMS FOR THE DEVICE. WHEN THE DEVICE WAS OUTSIDE THE PATIENT AND THE SCRUB NURSE WAS CLEANING THE DEVICE, THE DEVICE PROBE TIP FELL OFF. THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY WITH A SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE PHYSICIAN ENJOYS USING THIS DEVICE, PARTICULARLY FOR THE MASTECTOMY PROCEDURES; HOWEVER, THE PHYSICIAN IS STILL NOT VERY EXPERIENCED IN THE USE OF THE DEVICE AND TENDS TO ACTIVATE THE DEVICE WHILE TWISTING ON LARGE BITES OF TISSUE HOPING TO SPEED UP TISSUE TRANSECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13551044 ↗
• MalfunctionFeb 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC BREAST LUMPECTOMY PROCEDURE, THE DEVICE TEFLON PAD SEPARATED FROM THE UPPER JAW. THE TISSUES BEING TOUGH AND FIBROUS, THE SURGEON HAD APPLIED A LOT OF TORQUE AND TENSION ON THE DEVICE JAW WHILE MAKING MULTIPLE ATTEMPTS TO TRANSECT TOUGH, FIBROTIC TISSUES LEADING TO THE DETACHING OF THE TEFLON PAD. A NEW DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED, WITH A FEW MINUTES DELAY, BY USING THE CORRECT TECHNIQUE. THERE WERE NO FURTHER ISSUES. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE SURGEON IS A NEW USER OF THE DEVICE AND WAS HAPPY WITH THE PERFORMANCE OF THE DEVICE AND WILL CONTINUE TO USE THE DEVICE FOR PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514828 ↗
• MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, AFTER MORE THAN AN HOUR INTO A THERAPEUTIC GYNECOLOGY OBSTETRICS PROCEDURE THE TEFLON PAD DETACHED FROM THE DEVICE JAW AND FELL INTO THE PATIENT. THE FALLEN PIECE WAS RETRIEVED FROM THE PATIENT. A NEW DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH A DELAY OF 10 MINUTES. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. IT IS USUAL FOR THE INTELLIGENT TISSUE MONITORING (ITM) TO BE ON DURING PROCEDURES AT THE FACILITY; THE SETTING WAS NOT CHANGED DURING THE PROCEDURE. THE USER IS AWARE OF THE FUNCTIONALITY OF THE ITM, WHICH IS THAT IT IS A SUPPORT FUNCTION AND MAY NOT AT TIMES DETECT THAT THE TISSUE HAS BEEN CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446194 ↗