SonoSurg Scissors 5mm O.D.,non HF Series T3095Recalls & reported problems
Olympus Medical Systems Corp. · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170208539), received between Jun 7, 2021 and Jun 7, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2021Break; Break
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE APPLICATION SPECIALIST THAT DURING PREPARATION FOR THE PLANED PROCEDURE, THE PROBE WAS DEFECT AND DAMAGED. THE PRODUCT WAS PURCHASED ON 11.03.2020 THERE WAS NO PATIENT INJURY REPORTED. ON 2021/5/25 OMSC ACCEPTED THE SUBJECT DEVICE AND FOUND THAT THE TISSUE PAD WAS SEVERELY WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11945506 ↗
Other Instrument, ultrasonic surgical devices
- Harmonic ACE HARH36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical4 deaths7,609 reports
- Harmonic HARHD36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical1 recall2 deaths5,037 reports
- Harmonic ACE HAR36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical2,726 reports
- Harmonic HAR1136Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical2 deaths1,538 reports
- 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
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical2 recalls1 death970 reports
- Harmonic ACE HARH23Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical935 reports
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
- 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