BEUDAMED
    FDA Adverse Event Other Summary report: N

    STORZ LED LIGHT SOURCE, EIN: 751-002075

    MDR report key: 19647984 · Received June 28, 2024

    Report

    Report Number
    MW5156852
    Event Type
    Other
    Date Received
    June 28, 2024
    Date of Event
    January 11, 2024
    Report Date
    June 26, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    NTN
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER TIMEOUT, MULTIPLE MEMBERS OF THE SURGICAL TEAM WERE TALKING AT THE SAME TIME AND ASKING FOR EQUIPMENT TO BE TURNED ON AND ROOM LIGHTS OFF IN PREPARATION FOR CYSTOSCOPY. ROOM LIGHTS AND SPOTLIGHTS WERE ADJUSTED WHEN THE RESIDENT ASKED FOR "LIGHT ON" MULTIPLE TIMES, SO THE SCOPE LIGHT WAS SWITCHED FROM STANDBY TO ON. SCRUB TECH NOTICED A SMOKY SMELL AND PICKED UP THE LIGHT CORD. AN INSPECTION OF THE DRAPES REVEALED A BURN HOLE. DRAPES WERE PULLED BACK AND PATIENT'S SKIN WAS INSPECTED FOR ANY INJURY BY SURGEON AND STAFF IN THE ROOM. NO INJURY WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684727 STORZ LED LIGHT SOURCE, EIN: 751-002075 LED LIGHT SOURCE NTN KARL STORZ SE & CO. KG 20161420

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other