BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX SYSTEM RESECTOR HANDPIECE

    MDR report key: 8021529 · Received October 30, 2018

    Report

    Report Number
    1220948-2018-00091
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    September 30, 2018
    Report Date
    October 30, 2018
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663106561
    PMA / PMN Number
    K032387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION. WE OBSERVED THAT THE RUN BUTTON AND THE HERMETIC HEADER ASSEMBLY HAD BEEN REMOVED FROM THE BEZEL AND HOUSING. SOME OF THE WIRES THAT CONNECT THE MOTOR AND OTHER COMPONENTS TO THE END BELL CONNECTOR PINS HAD BEEN DISCONNECTED AND SOME OF THE WIRES WERE MISSING THE HEAT SHRINK. BASED ON THE CONDITION THE DEVICE WAS RECEIVED, IT IS LIKELY THE DEVICE WAS MANIPULATED WITH SOME ATTEMPT TO REPAIR. THE RESECTOR WOULD NOT ROTATE AND THE SURGEON WOULD NOT BE ABLE TO USE THIS DEVICE FOR THE PHLEBECTOMY PROCEDURE. BASED ON THE LIMITED AVAILABLE INFORMATION WE HAVE AT THIS TIME, WE ARE REPORTING THIS INCIDENT AS WE DO NOT HAVE ADEQUATE INFORMATION ABOUT HOW THE DEVICE WAS HANDLED AFTER THE EVENT AT THE USER FACILITY. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT SINCE THE ISSUE WAS DETECTED DURING PRE-USE CHECK. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDPIECE THAT THEY HAVE IN STOCK .

    Description of Event or Problem · 1

    DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861209 TRIVEX SYSTEM RESECTOR HANDPIECE HANDPIECE DWQ LEMAITRE VASCULAR, INC. 00840663106561

    Patients

    Seq Age Sex Outcome Treatment
    1