BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP

    MDR report key: 7957433 · Received October 11, 2018

    Report

    Report Number
    1220948-2018-00079
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 11, 2018
    Report Date
    October 11, 2011
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663106530
    PMA / PMN Number
    K032387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND WE HAVE CONFIRMED THE REPORTED INCIDENT. INITIALLY, WE OBSERVED THE CONTROL UNIT TO OPERATE ON ALL SETTINGS AND FUNCTIONS. HOWEVER, UPON FURTHER TESTING, WE NOTICED A HESITATION IN THE OPERATION OF THE RESECTOR AND OBSERVED THAT THE HARNESS CONNECTOR WAS LOOSE. THE CONNECTOR WAS MOST LIKELY DAMAGED BY THE OPERATOR WHILE MOVING THE RESECTOR POWER CABLE NEGLIGENTLY OR DURING INSERTION/REMOVAL OF THE RESECTOR POWER CABLE INTO THE CONTROL UNIT. A LOOSE CONNECTOR CAN CAUSE INTERMITTENT CONNECTION AND CAN CAUSE THE HANDPIECE TO OPERATE INTERMITTENTLY. THERE WAS NO INJURY TO THE PATIENT. THE ISSUE WAS DETECTED DURING PRE-USE CHECK AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT CONTROL UNIT.

    Description of Event or Problem · 1

    DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE WHEN IT WAS CONNECTED TO THE CONTROL UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797155 TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP VARICOSE VEIN ALBATION SYSTEM DWQ LEMAITRE VASCULAR, INC. 00840663106530

    Patients

    Seq Age Sex Outcome Treatment
    1