BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX SYSTEM RESECTOR HANDPIECE

    MDR report key: 8056680 · Received November 9, 2018

    Report

    Report Number
    1220948-2018-00098
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 8, 2018
    Report Date
    November 9, 2018
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663107391
    PMA / PMN Number
    K032387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION. THE HOUSING AND POWER CORD WERE VISUALLY INSPECTED AND WERE FOUND TO BE ACCEPTABLE. THE HANDPIECE STATUS LIGHT FLASHED GREEN WHEN THE DEVICE WAS CONNECTED TO THE CONTROL UNIT INDICATING AN ISSUE WITH THE HANDPIECE. THE DRIVE SHAFT DID NOT ROTATE WHEN THE WINDOW LOCK BUTTON WAS PRESSED. HOWEVER, THE DRIVE SHAFT ROTATED PROPERLY WHEN THE RUN BUTTON WAS PRESSED. UPON DISASSEMBLY OF THE HOUSING, WATER WAS OBSERVED INSIDE THE CORE TUBE. THE WINDOW LOCK REED SWITCH ON THE SWITCH PC BOARD WAS ALSO FOUND TO BE MALFUNCTIONING. THE ROOT CAUSE OF THE DEFECT WAS DETERMINED TO BE A DAMAGE TO THE PC BOARD DUE TO WATER EXPOSURE. WE CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPEN TO ADDRESS THIS ISSUE. THERE WAS NO INJURY TO THE PATIENT. THE MALFUNCTION WAS DETECTED PRIOR TO THE CASE.

    Description of Event or Problem · 1

    DURING PRE-USE CHECK, THE RESECTOR ON THE HANDPIECE DID NOT ROTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896295 TRIVEX SYSTEM RESECTOR HANDPIECE HANDPIECE DWQ LEMAITRE VASCULAR, INC. 00840663107391

    Patients

    Seq Age Sex Outcome Treatment
    1