SonoSurg Curved Scissors,Pistol Grip,5mm x 45cm T3795Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170235641), received between Jul 22, 2022 and Jul 22, 2022 — classified as 1 injury.
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
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2022Break; Break
OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "FRACTURE OF A PROBE TIP OF THE ULTRASONIC LAPAROSCOPIC COAGURATING SHEARS DURING LAPAROSCOPIC UTERINE FIBROID ENUCLEATION IN WHICH FALLEN DEBRIS WAS RECOVERED -A CASE REPORT". LITERATURE SUMMARY: ULTRASONIC LAPAROSCOPIC COAGULATING SHEARS (LCS) ARE SURGICAL INSTRUMENTS THAT CAN PERFORM COAGULATION AND INCISION AT THE SAME TIME BY ULTRASONIC VIBRATION AND ARE OFTEN USED IN LAPAROSCOPIC SURGERY. SINCE A LARGE FORCE IS APPLIED TO THE TIP OF THE PROBE, THE PROBE CAN BREAK DEPENDING ON THE USAGE CONDITIONS. A 43-YEAR-OLD WOMAN UNDERWENT LAPAROSCOPIC UTERINE MYOMECTOMY DUE TO UTERINE FIBROIDS. LCS BECAME AN ERROR MODE AT THE TIME OF MAKING A LONGITUDINAL INCISION IN THE MUSCULARIS LAYER OF THE POSTERIOR WALL OF THE UTERUS AND BECAME UNUSABLE. FRACTURE OF THE PROBE TIP WAS CONFIRMED. ALTHOUGH THE PART OF THE PROBE WAS SEARCHED IN THE SURGICAL FIELD AND THE EXTRACORPOREAL AREA, IT COULD NOT BE FOUND. IT WAS EVENTUALLY FOUND BY USING AN INTRAOPERATIVE X-RAY AND COULD BE REMOVED OUTSIDE THE BODY. POSTOPERATIVE INVESTIGATION POINTED OUT A SMALL DAMAGE THAT COINCIDED WITH THE FRACTURED PART. IT MIGHT BE THE CAUSE OF THE FRACTURE. WE PRESENT SOME PREC
Patient problems: Foreign Body In Patient
MAUDE report 15086092 ↗
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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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