BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASERSCOPE 800 SERIES KTP

    MDR report key: 1910757 · Received November 24, 2010

    Report

    Report Number
    1910757
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PEDIATRIC PATIENT WAS UNDERGOING A TONSILLECTOMY AND ADENOIDECTOMY WITH A KTP LASER. THE KTP LASER TESTED BY THE TECHNICIAN FROM THE CONTRACTED LASER PROVIDER PRIOR TO USE, AND PASSED. WHEN THE SURGEON TRIED USE THE KTP LASER DURING THE PROCEDURE, HE COULD NOT GET IT TO WORK. THE TECHNICIAN OBTAINED ANOTHER KTP LASER, BUT COULD NOT GET IT TO WORK EITHER. SURGEON WAS ABLE TO COMPLETE THE ADENOIDECTOMY, BUT UNABLE TO COMPLETE THE TONSILLECTOMY DUE TO THE MALFUNCTIONING KTP LASER. PATIENT WILL HAVE TO BE BROUGHT BACK TO COMPLETE THE TONSILLECTOMY. ALL OF THE HOSPITAL'S LASER EQUIPMENT AND SERVICES ARE PROVIDED BY A THIRD PARTY CONTRACTED LASER PROVIDER.THE LASER PROVIDER'S TECHNICIAN FELT IT MAY DUE TO THE FAILURE OF THE HANDPIECE ADAPTER, NOT THE KTP LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASERSCOPE 800 SERIES KTP LASER, SURGICAL, KTP/532 GEX AMERICAN MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR