BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFLEX LASER

    MDR report key: 21586329 · Received March 12, 2025

    Report

    Report Number
    MW5167580
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 3, 2025
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    365 LASER TIP BROKE INTRAOP. BROKEN PIECE RETRIEVED AND BROKEN FIBER REMOVED FROM FIELD AND GIVEN TO CLINICIAN. NEW 200 LASER FIBER OPENED AND CASE CONTINUED AS PLANNED. BARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701368 PROFLEX LASER POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC SU365PF 10124008

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female