THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm TB2-0535FCRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170440014), received between Jan 2, 2026 and Apr 24, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (K252150); they may or may not involve this specific model.
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
- Mar 23, 2026Class IIOpen, Classified
Potential for detachment of a distal tip component of the device during use.
Z-1853-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Melted1
- Peeled/Delaminated1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Unspecified Tissue Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Melted; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987600 ↗MalfunctionMar 26, 2026Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT GRIPPING SECTION WAS MELTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700686 ↗MalfunctionJan 16, 2026Peeled/Delaminated
IT WAS REPORTED THE THUNDERBEAT THE COVER OF THE TISSUE PAD CAME OFF. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24104829 ↗InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 23949760 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K252150. One submission often covers many models, so check the product and lot details in each record.
- Z-1851-2026 · Mar 23, 2026 · Open, ClassifiedOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
- Z-1852-2026 · Mar 23, 2026 · Open, ClassifiedOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
- Z-1854-2026 · Mar 23, 2026 · Open, ClassifiedOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
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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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