BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2538974 · Received April 12, 2012

    Report

    Report Number
    2538974
    Event Type
    Malfunction
    Date Received
    April 12, 2012
    Date of Event
    January 26, 2012
    Report Date
    April 6, 2012
    Manufacturer
    BIOLITEC MEDICAL DEVICES, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    WHILE SURGEON WAS USING THE LASER, A FIBER FRAGMENTED. ALL FRAGMENTS WERE REMOVED CYSTOSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LASER FIBER, SURGICAL GEX BIOLITEC MEDICAL DEVICES, INC. * A12-0027-C

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR