THUNDERBEAT Open Fine Jaw Type XRecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 76
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 3 models of THUNDERBEAT Open Fine Jaw Type X by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 76 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2022 and Aug 6, 2026 — classified as 4 injuries, 72 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (21 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. 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
Most reported THUNDERBEAT Open Fine Jaw Type X problems
Device problems
- Peeled/Delaminated21
- Detachment of Device or Device Component18
- Material Separation17
- Break8
- Fracture5
- Degraded4
- Naturally Worn4
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions76
THUNDERBEAT Open Fine Jaw Type X models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- THUNDERBEAT Open Fine Jaw Type X TB-0009OFXElectrosurgical, Cutting & Coagulation & Accessories37 reports
- THUNDERBEAT Open Fine Jaw Type X TB-0009OFXInstrument, ultrasonic surgical26 reports
- THUNDERBEAT Open Fine Jaw Type X TB-0009OFXElectrosurgical, cutting & coagulation & accessories13 reports
Recent THUNDERBEAT Open Fine Jaw Type X adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158801 ↗MalfunctionJun 3, 2026Material Fragmentation
THE CUSTOMER RETURNED THE THUNDERBEAT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE OLYMPUS SERVICE TECHNICIAN INDICATED THAT THE TISSUE PAD WAS WORN OUT, AND A PORTION OF IT WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25374752 ↗MalfunctionMay 29, 2026Peeled/Delaminated
THE CUSTOMER RETURNED THE THUNDERBEAT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING OLYMPUS¿ DEVICE ANALYSIS IT WAS INDICATED THAT THE THUNDERBEAT SURGICAL INSTRUMENT'S TISSUE PAD PEELED OFF . THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVEN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25340775 ↗MalfunctionApr 29, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT HAD PEELING OF THE TISSUE PAD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034053 ↗MalfunctionMar 12, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL INSTRUMENT TISSUE PAD IN THE GRASPING SECTION WAS WORN AWAY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24581695 ↗MalfunctionJan 23, 2026Crack; Peeled/Delaminated; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE OPEN FINE JAW TYPE X EXHIBITED PEELING OF THE TISSUE PAD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24160232 ↗MalfunctionJan 5, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23969443 ↗MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SUBJECT DEVICE HANDPIECE DISASSEMBLED WHILE IN USE DUE TO LOOSENING. THE ISSUE OCCURRED DURING A THERAPEUTIC THYROIDECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877784 ↗InjuryDec 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829575 ↗MalfunctionNov 20, 2025Naturally Worn; Naturally Worn
DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE TISSUE PAD IN THE GRASPING SECTION OF THE THUNDERBEAT DEVICE WAS WORN. NO PATIENTS WERE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23611987 ↗MalfunctionNov 17, 2025Naturally Worn; Naturally Worn
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE OPEN FINE JAW TYPE X EXHIBITED TISSUE PAD WAS WORN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23567765 ↗MalfunctionNov 14, 2025Naturally Worn; Naturally Worn
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE OPEN FINE JAW TYPE X EXHIBITED THE TISSUE PAD WAS UNEVENLY WORN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563422 ↗MalfunctionOct 29, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT EXHIBITED PEELING AWAY OF THE TISSUE PAD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23417515 ↗MalfunctionAug 29, 2025Peeled/Delaminated; Peeled/Delaminated
NO ADDITIONAL CUSTOMER INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929143 ↗MalfunctionAug 28, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE TISSUE PAD WAS PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22916112 ↗
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 16, 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