THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S TB-0545FCS (UDI 04953170383519)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04953170383519), received between Nov 5, 2018 and Nov 10, 2023 — classified as 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Break” (23 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. Nov 25, 2024Class IIOpen, Classified

   The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

   Z-0998-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE THUNDERBEAT SCISSOR WAS BROKEN OFF. THE ISSUE WAS FOUND DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THE FALLEN PART WAS RECOVERED SUCCESSFULLY, NO PATIENTS OR USERS WERE HARMED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18115077 ↗
• MalfunctionNov 2, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE ENERGY RELEASE OF THE THUNDERBEAT WAS NOT WORKING. UPON INSPECTION OF THE CUSTOMER¿S RETURNED DEVICE IT WAS OBSERVED, THE TISSUE PAD WAS FOUND WORN WITH METAL EXPOSED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055127 ↗
• InjuryJun 8, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A GASTRIC BYPASS PROCEDURE, THE JAW OF THIS ULTRASONIC SURGICAL DEVICE BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN OFF DEVICE WAS RETRIEVED FROM THE PATIENT, AS REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE, HOWEVER, UNSUCCESSFUL. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17092936 ↗
• InjuryJun 8, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A GASTRIC BYPASS PROCEDURE, THE JAW OF THIS ULTRASONIC SURGICAL DEVICE BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN OFF DEVICE WAS RETRIEVED FROM THE PATIENT, AS REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE, HOWEVER, UNSUCCESSFUL. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17092909 ↗
• MalfunctionMar 24, 2023Fracture; Fracture

  THE CUSTOMER REPORTED TO OLYMPUS, THE THUNDERBEAT PROBE WAS SKEWED/MISALIGNED WHILE BEING ACTIVATED IN THE PATIENT. THE ISSUE OCCURRED APPROXIMATELY 30 MINUTES AFTER USE DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE. THE INSTRUMENT WAS WITHDRAWN WITH PROBE STILL ATTACHED TO THE INSTRUMENT. PROBE DISLODGED FROM THE INSTRUMENT ONCE TOUCHED OUTSIDE OF PATIENT ON SCRUB TROLLEY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS A DELAY OF THREE MINUTES AND THE DURATION OF EXTENDED ANESTHESIA OR SEDATION WAS THREE MINUTES. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611718 ↗
• MalfunctionDec 23, 2022Break; Peeled/Delaminated; Break; Peeled/Delaminated

  THE CUSTOMER REPORTED THE INTRA-OPERATIVE BRANCH BROKE OFF INSIDE THE PATIENT AT THE BEGINNING OF A LAPAROSCOPIC SIGMOID PROCEDURE. THE FRAGMENT WAS RETRIEVED LAPAROSCOPICALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE AFTER A DELAY OF APPROXIMATELY FIVE MINUTES. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16043330 ↗
• MalfunctionDec 22, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, HALF WAY THROUGH A THERAPEUTIC LAPAROSCOPIC MYOMECTOMY PROCEDURE WHEN THE HARD FIBROID TISSUE WAS BEING CUT, THE DEVICE PROBE TIP BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT IMMEDIATELY. ANOTHER SIMILAR DEVICE WAS USED PRIOR TO THIS DEVICE. THE PROBE TIP OF THE EARLIER DEVICE HAD ALSO BROKEN OFF AND FALLEN IN THE PATIENT. THAT BROKEN PIECE WAS ALSO IMMEDIATELY REMOVED FROM THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES WITH A THIRD SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. PER THE CUSTOMER, THE HARD TISSUE OF THE FIBROID CONTRIBUTED TO THE BREAKING OF THE DEVICE PROBES. CUSTOMER WAS GOING TO EMPHASIZE TO THE USER THE PROPER WAY TO USE THE DEVICE TO PREVENT SUCH EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16036891 ↗
• MalfunctionDec 21, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING AN UNKNOWN THERAPEUTIC PROCEDURE A COUPLE OF UNKNOWN ERROR CODES WERE RECEIVED FOR THE DEVICE. APPROXIMATELY 10 MINUTES AFTER THE ERROR CODE WAS RECEIVED THE DEVICE PROBE BROKE OFF. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023649 ↗
• MalfunctionDec 16, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995366 ↗
• MalfunctionDec 2, 2022Break; Break

  ADDENDUM DEC 5, 2022: THE DEVICE PROBE BROKE OFF IN THE PATIENT. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT BODY LAPAROSCOPICALLY. THE PROCEDURE WAS COMPLETED WITH APPROXIMATELY FIVE MINUTES DELAY WITH NO CLINICAL RELEVANCE WITH A NEW SIMILAR DEVICE. ADDENDUM DEC 15, 2022: UPON EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE TISSUE PAD IN THE GRASPING SECTION WAS WORN AND PEELED BACK. THERE WAS NO MISSING PART TO THE TISSUE PAD. THIS IS A REPORTABLE MALFUNCTION OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15903565 ↗
• MalfunctionDec 2, 2022Break; Break

  ADDENDUM DEC 5, 2022: THE DEVICE PROBE BROKE OFF IN THE PATIENT. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT BODY LAPAROSCOPICALLY. THE PROCEDURE WAS COMPLETED WITH APPROXIMATELY FIVE MINUTES DELAY WITH NO CLINICAL RELEVANCE WITH A NEW SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15903521 ↗
• MalfunctionDec 1, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, THE DEVICE PROBE TIP BROKE OFF AND FELL INTO THE PATIENT WHILE BEING USED NORMALLY. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT BODY IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE OF THE SAME MODEL WHICH WAS IN STOCK AT THE FACILITY WITHOUT ISSUES. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15892508 ↗
• MalfunctionNov 29, 2022Break; Break

  THE CUSTOMER REPORTED THE PROBE BROKE OFF THE SUBJECT DEVICE AFTER APPROXIMATELY ONE HOUR OF USE DURING A GASTRIC BAND REMOVAL PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876868 ↗
• MalfunctionOct 18, 2022Break; Break

  CUSTOMER RETURNED THE DEVICE FOR EVALUATION OF A PROBE DAMAGE ERROR RECEIVED. THERE IS NO REPORTED HARM TO ANY PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DEVICE PROBE WAS BROKEN OFF APPROXIMATELY 17 MM FROM THE TIP. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE DEVICE PROBE TIP BEING BROKEN OFF AS OBSERVED DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626158 ↗
• MalfunctionOct 17, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, WHEN THE DEVICE WAS BEING USED FOR DISSECTION, AN ERROR MESSAGE WAS RECEIVED. THE DEVICE WAS TAKEN OUT OF THE PATIENT FOR CLEANING AND CLEARING THE ERROR MESSAGE. ONE OF THE JAWS OF THE DEVICE BROKE OFF AT THIS TIME. THE BROKEN PIECE WAS RECOVERED. THIS OCCURRED FOR TWO DEVICES. THERE IS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615518 ↗
• MalfunctionOct 17, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, WHEN THE DEVICE WAS BEING USED FOR DISSECTION, AN ERROR MESSAGE WAS RECEIVED. THE DEVICE WAS TAKEN OUT OF THE PATIENT FOR CLEANING AND CLEARING THE ERROR MESSAGE. ONE OF THE JAWS OF THE DEVICE BROKE OFF AT THIS TIME. THE BROKEN PIECE WAS RECOVERED. THIS OCCURRED FOR TWO DEVICES. THERE IS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615369 ↗
• MalfunctionOct 14, 2022Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THE PROCEDURE WAS COMPLETED UPON OPENING AND USING A SECONDARY THUNDERBEAT. ADDITIONALLY, IT WAS CONFIRMED THAT NO PART OF THE SUBJECT DEVICE REMAINED IN THE PATIENT AND THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612034 ↗
• MalfunctionOct 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED FOUR (4) THUNDERBEAT DEVICES WITH THE SAME MODEL AND LOT NUMBER (TB-0545FCS, LOT KR252813) FAILED DURING ONE PROCEDURE INVOLVING ONE PATIENT. THUNDERBEAT DEVICE 1 AND 2 DEVICES WERE REPORTED TO HAVE AN UNKNOWN PROBE DAMAGE ERROR WHEN THE SURGEON WAS MAKING LIGHT TISSUE CONTACT. THE THUNDERBEAT DEVICE 3 AND 4 DID NOT WORK AT ALL. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A FIFTH THUNDERBEAT DEVICE. THERE WAS A 30-45 MINUTE PROCEDURAL DELAY DUE TO THE DEVICE MALFUNCTIONS. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. THIS EVENT INCLUDES THE FOLLOWING 4 COMPLAINTS: (B)(6) DEVICE 1 OF 4 WITH UNKNOWN PROBE DAMAGE ERROR. (B)(6) DEVICE 2 OF 4 WITH UNKNOWN PROBE DAMAGE ERROR. (B)(6) DEVICE 3 OF 4, DIDN'T WORK. (B)(6) DEVICE 4 OF 4, DIDN'T WORK. THIS REPORT IS 1 OF 4 FOR(B)(6) DEVICE 1 OF 4 WITH UNKNOWN PROBE DAMAGE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607986 ↗
• MalfunctionOct 14, 2022Power Problem; Power Problem

  THE CUSTOMER REPORTED FOUR (4) THUNDERBEAT DEVICES WITH THE SAME MODEL AND LOT NUMBER (TB-0545FCS, LOT KR252813) FAILED DURING ONE PROCEDURE INVOLVING ONE PATIENT. THUNDERBEAT DEVICE 1 AND 2 DEVICES WERE REPORTED TO HAVE AN UNKNOWN PROBE DAMAGE ERROR WHEN THE SURGEON WAS MAKING LIGHT TISSUE CONTACT. THE THUNDERBEAT DEVICE 3 AND 4 DID NOT WORK AT ALL. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A FIFTH THUNDERBEAT DEVICE. THERE WAS A 30-45 MINUTE PROCEDURAL DELAY DUE TO THE DEVICE MALFUNCTIONS. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. THIS EVENT INCLUDES THE FOLLOWING 4 COMPLAINTS: (B)(6) : DEVICE 1 OF 4 WITH UNKNOWN PROBE DAMAGE ERROR. (B)(6) : DEVICE 2 OF 4 WITH UNKNOWN PROBE DAMAGE ERROR. (B)(6) : DEVICE 3 OF 4, DIDN'T WORK. (B)(6) : DEVICE 4 OF 4, DIDN'T WORK. THIS REPORT IS 3 OF 4 FOR(B)(6) : DEVICE 3 OF 4, DIDN'T WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607970 ↗
• MalfunctionOct 14, 2022Power Problem; Power Problem

  THE CUSTOMER REPORTED FOUR (4) THUNDERBEAT DEVICES WITH THE SAME MODEL AND LOT NUMBER (TB-0545FCS, LOT KR252813) FAILED DURING ONE PROCEDURE INVOLVING ONE PATIENT. THUNDERBEAT DEVICE 1 AND 2 DEVICES WERE REPORTED TO HAVE AN UNKNOWN PROBE DAMAGE ERROR WHEN THE SURGEON WAS MAKING LIGHT TISSUE CONTACT. THE THUNDERBEAT DEVICE 3 AND 4 DID NOT WORK AT ALL. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A FIFTH THUNDERBEAT DEVICE. THERE WAS A 30-45 MINUTE PROCEDURAL DELAY DUE TO THE DEVICE MALFUNCTIONS. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. THIS EVENT INCLUDES THE FOLLOWING 4 COMPLAINTS: (B)(6) DEVICE 1 OF 4 WITH UNKNOWN PROBE DAMAGE ERROR. (B)(6) DEVICE 2 OF 4 WITH UNKNOWN PROBE DAMAGE ERROR. (B)(6) DEVICE 3 OF 4, DIDN'T WORK. (B)(6) DEVICE 4 OF 4, DIDN'T WORK. THIS REPORT IS 4 OF 4 FOR (B)(6) DEVICE 4 OF 4, DIDN'T WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607963 ↗
• MalfunctionOct 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED FOUR (4) THUNDERBEAT DEVICES WITH THE SAME MODEL AND LOT NUMBER (TB-0545FCS, LOT KR252813) FAILED DURING ONE PROCEDURE INVOLVING ONE PATIENT. THUNDERBEAT DEVICE 1 AND 2 DEVICES WERE REPORTED TO HAVE AN UNKNOWN PROBE DAMAGE ERROR WHEN THE SURGEON WAS MAKING LIGHT TISSUE CONTACT. THE THUNDERBEAT DEVICE 3 AND 4 DID NOT WORK AT ALL. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A FIFTH THUNDERBEAT DEVICE. THERE WAS A 30-45 MINUTE PROCEDURAL DELAY DUE TO THE DEVICE MALFUNCTIONS. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. THIS EVENT INCLUDES THE FOLLOWING 4 COMPLAINTS: (B)(6) DEVICE 1 OF 4 WITH UNKNOWN PROBE DAMAGE ERROR. (B)(6) DEVICE 2 OF 4 WITH UNKNOWN PROBE DAMAGE ERROR. (B)(6) DEVICE 3 OF 4, DIDN'T WORK. (B)(6) DEVICE 4 OF 4, DIDN'T WORK. THIS REPORT IS 2 OF 4 FOR (B)(6) : DEVICE 2 OF 4 WITH UNKNOWN PROBE DAMAGE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607956 ↗
• MalfunctionSep 13, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC LAPAROSCOPIC SIGMA PROCEDURE THE DEVICE PROBE TIP BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY AND NORMALLY COMPLETED WITH NEW SIMILAR DEVICE. THERE WAS A SLIGHT PROLONGATION OF THE PROCEDURE, WHICH WAS NOT RELEVANT. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT OR ANY OTHER PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414556 ↗
• MalfunctionApr 6, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER RETURNED THE DEVICE FOR EVALUATION OF A BURN OBSERVED ON THE DEVICE DURING A COLON RESECTION PROCEDURE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SIMILAR DEVICE. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE TISSUE PAD OF THE DEVICE WAS WORN AND PEELED BACK FROM THE TIP EXPOSING METAL OF THE GRASPING PART. THERE IS NO MISSING PART TO THE TISSUE PAD. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE PEELED BACK TISSUE PAD EXPOSING METAL OBSERVED DURING DEICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14028434 ↗
• MalfunctionFeb 22, 2022Break; Break

  A USER FACILITY REPORTED TO OLYMPUS THE THUNDERBEAT PRODUCED AN UNSPECIFIED ERROR MESSAGE WHILE DOING THE PROBE CHECK DURING PREPARATION FOR USE OF THE DEVICE. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, IT WAS OBSERVED THE PROBE IS DETACHED AND NOT RETURNED WITH THE UNIT. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578144 ↗
• MalfunctionJan 7, 2021Break; Break

  HOLD FOR AT 1.22

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11129184 ↗