BEUDAMED
    FDA Adverse Event Other Summary report: N

    ND: YAG LASER FIBER

    MDR report key: 30460 · Received January 2, 1996

    Report

    Report Number
    30460
    Event Type
    Other
    Date Received
    January 2, 1996
    Date of Event
    October 31, 1995
    Report Date
    November 10, 1995
    Manufacturer
    SURGICAL LASER TECHNOLOGIES, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LASER OVERHEATED SURROUNDING INSTRUMENT, CAUSING LIP BURN. ON FOLLOW UP EXAM OF LASER FIBER HANDPIECE, FIBER WAS NOTED TO BE PROTRUDING FROM HANDPIECE TIP, CAUSING UNEVEN HEAT TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ND: YAG LASER FIBER LASER FIBER GEX SURGICAL LASER TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other