BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASE

    MDR report key: 415055 · Received August 29, 2002

    Report

    Report Number
    415055
    Event Type
    Other
    Date Received
    August 29, 2002
    Date of Event
    August 15, 2002
    Report Date
    August 26, 2002
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    GEX
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LASER FIBER INTACT WHEN CHECKED PRIOR TO OPERATING ROOM. FIBER INSERTED INTO TROCAR INTO PT. WHEN DR FIRED THE LASER, THE TIP OF THE FIBER LOOKED AS IF IT HAD BEEN CUT. LASER FIBER REMOVED FROM PT. NEW FIBER OPENED AND PROCEDURE FINISHED.

    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