BEUDAMED
    FDA Adverse Event Summary report: N

    PROFLEX 200 LASER LITHOTRIPSY FIBER

    MDR report key: 7697701 · Received July 17, 2018

    Report

    Report Number
    MW5078447
    Date Received
    July 17, 2018
    Date of Event
    June 28, 2018
    Report Date
    July 16, 2018
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CYSTO URETEROSCOPY WITH STENT INSERTION. SURGEON ATTEMPTED TO USE THE LASER FIBER WITH LITTLE RESULT. POWER WAS INCREASED WITHOUT CHANGE. FIBER WAS DISCONNECTED AND RECONNECTED. NO CHANGE NOTED. A NEW LASER FIBER WAS THEN CONNECTED AND THE PROCEDURE PROCEEDED WITHOUT COMPLICATIONS; BARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536989 PROFLEX 200 LASER LITHOTRIPSY FIBER POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC

    Patients

    Seq Age Sex Outcome Treatment
    1