THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCS (UDI 04953170383540)Recalls & reported problems
Olympus Medical Systems Corp. · THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S · Class U
All models of THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus THUNDERBEAT ultrasonic surgical instrument cuts and seals tissue during surgery. Of its 1,128 reports, 2 describe a patient death, 257 describe injuries and 869 describe malfunctions. Many reports describe jaws or tips breaking off during surgery, with pieces sometimes falling into the body. Reports fell to 16 in the last 12 months from 55 in the previous 12 months. 3 open recalls cover broken or damaged tips and a removal due to continued adverse event reports.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,128
- Deaths reported
- 2
- Injuries reported
- 257
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 1,128 adverse event reports that list this exact device (DI 04953170383540), received between Jun 22, 2018 and Jun 10, 2026 — classified as 2 deaths, 257 injuries, 869 malfunctions.
The most frequently reported specific device problem is “Break” (680 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.
Reports received per month
Recalls naming this device
- Oct 22, 2025Class IIOpen, Classified
Firm is initiating a removal due to continued reports of adverse events.
Z-1372-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 25, 2024Class IIOpen, Classified
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-0993-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 25, 2024Class IIOpen, Classified
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-0997-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break680
- Detachment of Device or Device Component233
- Fracture93
- Material Separation90
- Peeled/Delaminated64
- Adverse Event Without Identified Device or Use Problem28
- Activation Problem21
- Degraded21
Patient problems
- No Clinical Signs, Symptoms or Conditions837
- No Consequences Or Impact To Patient173
- No Known Impact Or Consequence To Patient48
- Foreign Body In Patient34
- Hemorrhage/Blood Loss/Bleeding12
- Insufficient Information8
- Fistula7
- Unspecified Kidney or Urinary Problem4
Recent adverse event reports
The 25 most recent of 1,128 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2026Detachment of Device or Device Component
IT WAS REPORTED THE ULTRASONIC SURGICAL DEVICE BUTTON JAW BROKE OFF UPON GRABBING AND CAUTERIZING THE TISSUE DURING A THERAPEUTIC HYSTERECTOMY. THE BROKEN PIECE WAS RETRIEVED WITH A SEPARATE LAPAROSCOPIC GRASPER, AND THERE WAS A SLIGHT DELAY TO RETRIEVE THE BROKEN PIECES. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459425 ↗MalfunctionJun 10, 2026Detachment of Device or Device Component
IT WAS REPORTED THE 2ND ULTRASONIC SURGICAL DEVICE BUTTON JAW ALSO BROKE OFF UPON GRABBING AND CAUTERIZING THE TISSUE DURING A THERAPEUTIC HYSTERECTOMY. THE BROKEN PIECE WAS RETRIEVED WITH A SEPARATE LAPAROSCOPIC GRASPER, AND THERE WAS A SLIGHT DELAY TO RETRIEVE THE BROKEN PIECES. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25457809 ↗MalfunctionJun 10, 2026Detachment of Device or Device Component
IT WAS REPORTED THE ULTRASONIC SURGICAL DEVICE BUTTON JAW BROKE OFF UPON GRABBING AND CAUTERIZING THE TISSUE DURING A THERAPEUTIC HYSTERECTOMY. THE BROKEN PIECE WAS RETRIEVED WITH A SEPARATE LAPAROSCOPIC GRASPER, AND THERE WAS A SLIGHT DELAY TO RETRIEVE THE BROKEN PIECES. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25457735 ↗MalfunctionJun 8, 2026Peeled/Delaminated
THE CUSTOMER RETURNED THE THUNDERBEAT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, A PARTIALLY DETACHED TEFLON TISSUE PAD WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25435256 ↗MalfunctionMay 29, 2026Detachment of Device or Device Component
THE CUSTOMER REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S TIP BROKE OFF IN HALF AND FELL INTO THE ABDOMINAL CAVITY DURING A LAPAROSCOPIC HYSTERECTOMY. INITIALLY, THE THUNDERBEAT REPORTED A MALFUNCTION. THE TIP DID NOT HIT METAL AND WAS NOT CRUSTED, BUT WAS IN NORMAL USE. NOTHING WAS VISIBLE EXTERNALLY. THE THUNDERBEAT MACHINE WAS TURNED OFF AND RESTARTED. THE PROCEDURE CONTINUED NORMALLY FOR A SHORT TIME UNTIL THE MESSAGE CAME BACK THAT THE TIP WAS DAMAGED. WHEN THE HANDPIECE WAS OUT OF THE ABDOMINAL CAVITY, IT WAS NOTICED THAT ONE HALF OF THE TIP HAD BROKEN OFF AND FALLEN INTO THE ABDOMINAL CAVITY. THE PIECE OF THE TIP WAS EASILY FOUND AND REMOVED. THIS RESULTED IN A DELAY IN THE PROCEDURE OF 30 MINUTES. THE PROCEDURE WAS COMPLETED USING A BACK UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25340519 ↗MalfunctionMar 31, 2026Fracture; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741986 ↗MalfunctionJan 30, 2026Naturally Worn
IT WAS OBSERVED THAT DURING THE EVALUATION, THE THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S EXHIBITED THAT THE TISSUE PAD WAS WORN OFF. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228716 ↗MalfunctionJan 14, 2026Break
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24072568 ↗MalfunctionDec 18, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE TEFLON TISSUE PAD ON THE THUNDERBEAT DEVICE PEELED OFF AFTER SIX (6) ACTIVATIONS AT THE START OF THE PROCEDURE, RESULTING IN AN EXTENDED PROCEDURAL DELAY OF LESS THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING AN OLYMPUS BACKUP DEVICE, AND NO PATIENT HARM WAS REPORTED IN ASSOCIATION WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23844258 ↗MalfunctionDec 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE FRONT-ACTUATED GRIP TYPE S EXHIBITED THE TISSUE PAD WAS PEELING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789205 ↗MalfunctionDec 3, 2025Break; Melted; Break; Melted
NO NEW INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708857 ↗MalfunctionNov 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 23638137 ↗InjuryNov 20, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPIC SUBTOTAL HYSTERECTOMY VIA A HIGH APPROACH, THE ULTRASONIC FORCEPS MALFUNCTIONED, AND BROKEN GRASPING FORCEPS WERE OBSERVED. THE FORCEPS BROKE AT THE END OF THE SURGERY, ABOUT 90% COMPLETE, RETRIEVED THROUGH AN UNSPECIFIED MEDICAL INTERVENTION WITH NO PIECES LEFT INSIDE THE PATIENT, AND NO SEQUELAE WERE REPORTED FOR THE PATIENT RELATED TO THE BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23606977 ↗MalfunctionNov 15, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE LOWER JAW BROKE DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. LOWER JAW BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563511 ↗MalfunctionNov 12, 2025Degraded; Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE EXHIBITED A WORN TEFLON PAD WITH METAL EXPOSED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536945 ↗MalfunctionNov 6, 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 23490607 ↗InjuryOct 29, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23411020 ↗MalfunctionOct 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THE THUNDERBEAT TIP BROKE OFF AT THE BEGINNING OF THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23328884 ↗MalfunctionSep 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23043093 ↗InjurySep 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: Foreign Body In Patient
MAUDE report 22939205 ↗MalfunctionAug 1, 2025Naturally Worn; Naturally Worn
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE TISSUE PAD ON THE THUNDERBEAT DEVICE HAD WORN OUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22692281 ↗MalfunctionAug 1, 2025Naturally Worn; Naturally Worn
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE TISSUE PAD ON THE THUNDERBEAT DEVICE HAD WORN OUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22690141 ↗MalfunctionJul 24, 2025Material Separation; Material Separation
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22584906 ↗InjuryJul 10, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PROBE BROKE DURING COLPOTOMY. THE BROKEN BLADE FELL INTO THE ABDOMEN AND WAS RETRIEVED WITHIN A FEW SECONDS. THE PROCEDURE WAS PROLONGED FOR A FEW MINUTES TO OPEN A NEW DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22468830 ↗MalfunctionJul 2, 2025Material Disintegration; Material Disintegration
IT WAS REPORTED THE INSULATION OF THE THUNDERBEAT DISINTEGRATED DURING USE. IT WAS REPORTED THAT THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22386506 ↗
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- THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical3 recalls1,373 reports
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical2 recalls1 death970 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page