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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

Other Instrument, ultrasonic surgical devices

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Sources and updates

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