BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX SYSTEM RESECTOR HANDPIECE

    MDR report key: 7097753 · Received December 7, 2017

    Report

    Report Number
    1220948-2017-00068
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 6, 2017
    Report Date
    December 7, 2017
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663106561
    PMA / PMN Number
    K032387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. WHEN THE HANDPIECE WAS PLUGGED INTO THE CONTROL UNIT, THE DEVICE HESITATED TO ROTATE FOR 30 SECONDS DESPITE PRESSING THE RUN BUTTON BUT ROTATED AT 1600 RPMS FO A 5 MINUTES LATER ON WITH NO FURTHER ISSUE. HOWEVER, WHEN THE RUN BUTTON ON THE HANDPIECE WAS PRESSED INTERMITTENTLY, THE MDU STATUS LIGHT ON CONTROL UNIT WOULD FLASH GREEN INDICATING A FAILURE IN THE MDU'S MOTOR UNIT. ALSO, THE BLADE WOULD ROTATE 180 DEGREES BEFORE COMING TO A COMPLETE STOP. THE MOTOR WAS TESTED SEPARATELY AND FAILED FUNCTIONALITY TESTING. THEREFORE, MOTOR FAILURE WAS THE ROOT CAUSE LIKELY FROM AGE AND EXCESSIVE WORN AND TEAR FROM REPEATED USE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS ISSUE.

    Description of Event or Problem · 1

    THE BUTTON FOR POSITIONING THE RESECTOR BLADE DID NOT WORK PROPERLY. IT WAS DIFFICULT FOR THE PHYSICIAN TO POSITION THE BLADE CORRECTLY SINCE THE BLADE ROTATED DESPITE RELEASING THE RUN BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878012 TRIVEX SYSTEM RESECTOR HANDPIECE HANDPIECE DWQ LEMAITRE VASCULAR, INC. 00840663106561

    Patients

    Seq Age Sex Outcome Treatment
    1