BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFLEX 200 HOLMIUM FIBER

    MDR report key: 12266711 · Received August 2, 2021

    Report

    Report Number
    MW5102936
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    July 14, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BARD / INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BARD PROFLEX 200 LASER FIBER WAS USED DURING SURGERY AND THE TIP BROKE OFF IN THE PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160873 PROFLEX 200 HOLMIUM FIBER POWERED LASER SURGICAL INSTRUMENT GEX BARD / INNOVAQUARTZ LLC LSU200PF 09221003

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR