THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type SRecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
5 open recalls name at least one THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3,471
- Deaths reported
- 3
- Injuries reported
- 519
- Recalls
- 5
We found 3 models of THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 3,471 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2018 and Sep 17, 2026 — classified as 3 deaths, 519 injuries, 2,949 malfunctions.
The most frequently reported specific device problem is “Break” (2,293 reports).
5 FDA recall records name at least one of these models by its device identifier, 5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 3 of these models · 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 ↗
- 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 ↗
- 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 · names 2 of these models · Recall details · FDA record ↗
- Sep 12, 2023Class IIOpen, Classified
Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery
Z-0108-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S problems
Device problems
- Break2,293
- Detachment of Device or Device Component618
- Fracture235
- Peeled/Delaminated218
- Material Separation211
- Degraded108
- Naturally Worn49
- Material Split, Cut or Torn40
Patient problems
- No Clinical Signs, Symptoms or Conditions2,287
- No Consequences Or Impact To Patient971
- No Known Impact Or Consequence To Patient75
- Foreign Body In Patient68
- Insufficient Information29
- Hemorrhage/Blood Loss/Bleeding22
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Fistula7
THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S TB-0535FCSInstrument, ultrasonic surgical3 recalls1,373 reports
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCSInstrument, ultrasonic surgical3 recalls2 deaths1,128 reports
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCSInstrument, ultrasonic surgical2 recalls1 death970 reports
Recent THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Detachment of Device or Device Component
The customer returned the Thunderbeat surgical instrument to the service center for a separate issue. During Olympus¿ device analysis it was indicated that the Thunderbeat surgical instrument's tissue grasping insulation pad was split and detached. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805862 ↗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 23, 2026Fracture
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE PROBE AT THE PROXIMAL TIP OF THE THUNDERBEAT DEVICE BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598286 ↗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 ↗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 Discolored
THE CUSTOMER RETURNED THE FRONT-ACTUATED GRIP TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE EVALUATION INDICATES THAT A TISSUE PAD CHAR MARK WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354636 ↗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 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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