SonoSurg Curved Scissors,HF,Inline Grip,5mm x 19cm T3925Recalls & reported problems
Olympus Medical Systems Corp. · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170235702), received between Sep 15, 2022 and Jun 26, 2024 — classified as 2 injuries, 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
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2024Break; Break
IT WAS REPORTED THE TIP OF THE ULTRASONIC CURVED SCISSORS BROKE WHEN THE SURGEON REMOVED IT FROM THE BODY. THE TIP DID NOT FALL INSIDE THE CUSTOMER'S BODY. THE ISSUE OCCURRED AT THE END OF A THERAPEUTIC LAPAROSCOPIC INGUINAL HERNIA REPAIR. NO DELAY TO THE PROCEDURE WAS REPORTED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19615039 ↗InjuryAug 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING AN OPEN LIVER RESECTION, THE PROBE ON THE SONOSURG CURVED SCISSORS BROKE AND FELL OUT OF THE PATIENT'S BODY. THE FALLEN PIECE WAS COLLECTED AND SWITCHED TO A NEW SIMILAR DEVICE, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO HEALTH HAZARDS TO PATIENTS AND NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17654910 ↗InjurySep 15, 2022Overheating of Device; Overheating of Device
THE CUSTOMER REPORTED AFTER A DISTAL PANCREATECTOMY USING SONOSURG SCISSORS, BURNS WERE FOUND ON THE PATIENT THAT WERE CLOSE TO THE SIZE OF THE SONOSURG SCISSORS. INTRAOPERATIVELY, THE SONOSURG SCISSORS HAD BEEN PLACED ON THE PATIENT. THE EXACT LOCATION AND SEVERITY OF THE BURN WAS NOT PROVIDED. IT IS UNKNOWN IF THE PATIENT REQUIRED TREATMENT/INTENTION FOR THE BURN. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Burn(s)
MAUDE report 15429446 ↗
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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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