THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCS (UDI 04953170383557)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
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus THUNDERBEAT is an ultrasonic surgical instrument used in surgery. Most of its 969 reports describe breaking parts, tissue pads wearing or peeling off, and detaching components, and a few mention foreign material left in the patient. The reports mention 1 death and 87 injuries. Two recalls are open, from November 2024 over damaged probe tips and October 2025 over continuing 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
- 970
- Deaths reported
- 1
- Injuries reported
- 87
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 970 adverse event reports that list this exact device (DI 04953170383557), received between Jun 29, 2018 and Aug 14, 2026 — classified as 1 death, 87 injuries, 882 malfunctions.
The most frequently reported specific device problem is “Break” (647 reports).
2 FDA recall records name this device's identifier, 2 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-0996-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break647
- Detachment of Device or Device Component111
- Peeled/Delaminated78
- Fracture73
- Material Separation52
- Degraded49
- Naturally Worn25
- Material Fragmentation12
Patient problems
- No Clinical Signs, Symptoms or Conditions666
- No Consequences Or Impact To Patient284
- Foreign Body In Patient12
- Hemorrhage/Blood Loss/Bleeding6
- Insufficient Information5
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Biliary Leak1
Recent adverse event reports
The 25 most recent of 970 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Detachment of Device or Device Component
The customer returned the Ultrasonic Surgical Device to the service center for a separate issue. During the device analysis, the service repair technician indicated the tissue pad was worn away. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251395 ↗MalfunctionAug 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209406 ↗MalfunctionAug 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209365 ↗MalfunctionAug 6, 2026Flaked
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158733 ↗MalfunctionJul 9, 2026Naturally Worn
IT WAS REPORTED BY THE CUSTOMER THAT, DURING A THERAPEUTIC DISTAL GASTRECTOMY PROCEDURE, A SHORT CIRCUIT ERROR WAS DISPLAYED ON THE THUNDERBEAT ENERGY DEVICE. DURING DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS IDENTIFIED: THE TISSUE PAD WAS WORN AWAY. THE INTENDED PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25770771 ↗MalfunctionJun 2, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, EXHIBITED THE BROKEN PORTION (SHAFT) EXHIBITED A CHARACTERISTIC OF DUCTILE FRACTURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25369094 ↗MalfunctionJun 2, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE FRONT-ACTUATED GRIP EXHIBITED THE TISSUE PAD HAD PEELED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25368798 ↗MalfunctionJun 1, 2026Material Fragmentation
THE CUSTOMER RETURNED THE ULTRASONIC SURGICAL DEVICE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, A SEVERELY WORN OUT TISSUE PAD WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354573 ↗MalfunctionJun 1, 2026Peeled/Delaminated
THE CUSTOMER RETURNED THE ULTRASONIC SURGICAL DEVICE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE TISSUE PAD WAS FOUND WORN OUT AND PARTIALLY PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349058 ↗MalfunctionJun 1, 2026Material Fragmentation
THE CUSTOMER RETURNED THE ULTRASONIC SURGICAL DEVICE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, A SEVERELY WORN OUT TISSUE PAD WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349008 ↗MalfunctionJun 1, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT TISSUE PAD PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348842 ↗MalfunctionMay 26, 2026Naturally Worn
THE CUSTOMER RETURNED THE THUNDERBEAT, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, TISSUE PAD WAS WORN AWAY WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE TISSUE PAD BEING WORN AWAY WAS DUE TO A WEAR PROBLEM IDENTIFIED WITH THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278141 ↗MalfunctionMay 21, 2026Material Fragmentation; Peeled/Delaminated
IT WAS OBSERVED DURING THE EVALUATION THAT THE THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S EXHIBITED THAT THE TISSUE PAD WAS WORN OUT AND PARTIALLY PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25250573 ↗MalfunctionApr 23, 2026Fracture
IT WAS REPORTED THE ULTRASONIC SURGICAL DEVICE TIP BROKE DURING A THERAPEUTIC COLECTOMY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24969075 ↗MalfunctionMar 31, 2026Crack; Peeled/Delaminated
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24749826 ↗MalfunctionMar 24, 2026Fracture
IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S TIP BROKE OFF INTO THE PATIENT'S INTRA-ABDOMINAL ANATOMY DURING A CHOLECTOMY PROCEDURE. THE FRAGMENT WAS RETRIEVED WITH FORCEPS IMMEDIATELY AND DID NOT REQUIRE FURTHER INTERVENTION. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681121 ↗MalfunctionMar 20, 2026Fracture
IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S FORCEPS COMPONENT DETACHED AND FELL OFF WITHIN INTRAPERITONEAL CAVITY DURING A HYSTERECTOMY PROCEDURE. THE FRAGMENT WAS RETRIEVED, THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651450 ↗MalfunctionMar 18, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S EXHIBITED THAT THE TIP WAS BROKEN. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENTS¿ HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24628625 ↗MalfunctionMar 10, 2026Fracture
NO NEW INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24563840 ↗MalfunctionMar 10, 2026Fracture
NO NEW INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24563563 ↗MalfunctionFeb 27, 2026Break
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24476350 ↗MalfunctionFeb 27, 2026Fracture
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469940 ↗MalfunctionFeb 27, 2026Fracture
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469729 ↗MalfunctionFeb 20, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402605 ↗MalfunctionFeb 19, 2026Fracture
UPDATE FROM THE CUSTOMER: THE ISSUE OCCURRED DURING A CHOLECYSTECTOMY PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24394417 ↗
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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 surgical3 recalls2 deaths1,128 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.
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