BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASE

    MDR report key: 415036 · Received August 29, 2002

    Report

    Report Number
    415036
    Event Type
    Malfunction
    Date Received
    August 29, 2002
    Date of Event
    August 15, 2002
    Report Date
    August 26, 2002
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING LASE PROCEDURE DOCTOR FELT WARMTH BY THEIR LEFT LEG, LOOKED DOWN. FIBER CRACKED, LASER TURNED OFF. NEW FIBER GIVEN TO SURGEON. SURGEON'S GOWN AND DRAPE WAS CHARRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASE ENDOSCOPIC DISCECTOMY GEX CLARUS MEDICAL, LLC. 1100-002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other