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N/A 05-0760ledRecalls & reported problems

SCHÖLLY FIBEROPTIC GmbH · LED Light Source · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04250480107645), received between Nov 9, 2020 and Nov 9, 2020 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING A 4K PROCEDURE, THE SCRUB NURSE NEGLECTED TO CONNECT A LAPAROSCOPE, TURNED THE LED LIGHT SOURCE AND PLACED THE CABLE ON THE DRAPE TOP OF THE PATIENT. AFTER THE PROCEDURE CONCLUDED, IT WAS NOTED THAT THE CABLE TIP HAD BURNED A HOLE IN THE DRAPE AND THE BURN WENT THROUGH ALL THE WAY CREATING A BURN ON THE PATIENT APPROX. 1/4 " IN THE PELVIC AREA.

    Patient problems: Burn(s)

    MAUDE report 10809121 ↗

Other Led Light Source devices

All Led Light Source devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.