BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YAG SL SERIES

    MDR report key: 1850470 · Received September 28, 2010

    Report

    Report Number
    1850470
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MEDICAL ENERGY, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US

    Narratives

    Description of Event or Problem · 1

    THE YAG LASER WAS BEING USED AND THE TIP BROKE OFF IN THE BLADDER. THE TIP WAS RETRIEVED BY THE PHYSICIAN. THERE WAS NO HARM TO THE PATIENT. THE TIP WAS IN ONE PIECE AND INTACT. FIBER WAS CLEANED AND SECURED IN THE OR. MANUFACTURER WILL BE NOTIFIED FOR INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YAG SL SERIES LASER, SURGICAL, YAG GEX MEDICAL ENERGY, INC. LF 100 NW8291
    2 UROLIGHT LASER FIBER GEX MEDICAL ENERGY, INC. * 2679B

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR