NA 11.0057aRecalls & reported problems
SCHÖLLY FIBEROPTIC GmbH · Laparoscope 5 x 312 mm, 30° · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250480102336), received between Nov 13, 2025 and Aug 17, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
- No Apparent Adverse Event1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50288423 ↗MalfunctionNov 13, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING CENTRAL PROCESSING THERE WAS A SHARP EDGE AT THE TIP OF THE LENS. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 23548453 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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