BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUNDED LASER PROBE

    MDR report key: 29570 · Received January 29, 1996

    Report

    Report Number
    MW1008213
    Event Type
    Malfunction
    Date Received
    January 29, 1996
    Date of Event
    December 27, 1995
    Report Date
    January 3, 1996
    Manufacturer
    SURGICAL LASER TECHNOLOGIES,INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING LASER LAPAROSCOPY IT WAS NOTICED THAT TIP OF ROUNDED LASER PROBE HAD BROKEN OFF. STERILE FIELD AND SURROUNDING AREA SEARCHED. UNABLE TO LOCATE LASER TIP. THE MD IS AWARE. THE PROBE TIP CRYSTAL IS NOT X-RAY DETECTIBLE, NOT EVEN SURE IF IT VAPORIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUNDED LASER PROBE LASER PROBE GEX SURGICAL LASER TECHNOLOGIES,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other