BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFLEX

    MDR report key: 10585875 · Received September 25, 2020

    Report

    Report Number
    10585875
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    July 11, 2020
    Report Date
    August 31, 2020
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROFLEX 273 LASER FIBER MALFUNCTIONED WHILE BEING FIRED INTRAOPERATIVELY. A SPARK WAS NOTED AND THE LASER FIBER WAS FOUND TO BE BROKEN. THERE WERE NO ERROR MESSAGES ON THE LASER MACHINE PRIOR TO EVENT. NO PATIENT HARM. ANOTHER FIBER WAS USED AFTER RESTARTING THE LASER MACHINE AND NO FURTHER MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049223 PROFLEX POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC LSU273PF LOT:31219003

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA