SonoSurg Curved Scissors,HF,Inline Grip,5mm x 9cm T3955Recalls & reported problems
Olympus Medical Systems Corp. · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170235733), received between Sep 25, 2023 and Jun 17, 2024 — classified as 1 injury, 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED WHEN THE PRODUCT WAS DISASSEMBLED DURING REPROCESSING AFTER A CORONARY ARTERY BYPASS GRAFTING (CABG), IT WAS NOTICED THAT THE BLACK RUBBER RING ATTACHED TO THE ACTIVE BLADE WAS MISSING. THE PROCEDURE HAD ALREADY BEEN COMPLETED AND THERE WAS NO IMPACT ON THE PROCEDURE OR PATIENTS HEALTH. THE PATIENT'S CURRENT STATUS IS UNKNOWN. THE FALLEN RUBBER RING WAS NOT COLLECTED. PER THE FACILITY, IF THE RUBBER RING CAN FALL OFF WHEN THE PRODUCT IS ASSEMBLED, IT IS ASSUMED THAT THERE IS A POSSIBILITY THAT IT MAY HAVE FALLEN OFF INSIDE THE PATIENT'S BODY AND THE MOST LIKELY LOCATION WOULD BE THE POSTERIOR PART OF THE LOWER LEG.
Patient problems: Foreign Body In Patient
MAUDE report 19554067 ↗MalfunctionSep 25, 2023Break; Break
AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PROBE TIP OF THE SONOSURG CURVED SCISSORS, HF, INLINE GRIP, 5MM X 9CM BROKE WHEN IT RELEASED THE TISSUE UPON OUTPUT OR ATTEMPT TO OUTPUT. NO PART OF THE DEVICE FELL OFF INTO THE PATIENT'S BODY. THE OUTPUT WAS NORMAL AND SET AT 100% AND ARBITRARY SETTING WAS AT 70%. THE ISSUE OCCURRED DURING A RETECTOMY BY LAPAROTOMY AND WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE OUTPUT WAS CHECKED PRIOR TO USE WITHOUT ANY ISSUES NOTED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17811915 ↗
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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
- 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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