BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFLEX 365

    MDR report key: 6173750 · Received December 14, 2016

    Report

    Report Number
    6173750
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 21, 2016
    Manufacturer
    INNOVAQUARTZ,LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A NOTED BREAK IN THE HOLMIUM FIBER. THE BREAK LEAD TO SEARING OF THE SURGICAL DRAPE, RESULTING IN A HOLE LESS THEN ONE CM DIAMETER. THE LASER DID NOT PENETRATE THE STIRRUP BOOT COVERING THE DRAPE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824805 PROFLEX 365 LASER FIBER GEX INNOVAQUARTZ,LLC 14516-009

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR