BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER POWERTOUCH

    MDR report key: 3170032 · Received June 7, 2013

    Report

    Report Number
    MW5030527
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MEDICAL ENERGY INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRAOPERATIVELY LASER TIP FIBER BROKE OFF IN THE PT DURING A TONSILLECTOMY CASE WHICH WAS RETRIEVED FROM PT'S THROAT WITH SCOPE AND GRASPER. REASON FOR USE: LASER USED DURING TONSILLECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253757 LASER POWERTOUCH LASER TIP GEX MEDICAL ENERGY INC 1063C

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO