BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX SYSTEM RESECTOR HANDPIECE

    MDR report key: 7100933 · Received December 8, 2017

    Report

    Report Number
    1220948-2017-00069
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Report Date
    December 8, 2017
    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 NOT RECEIVED THE DEVICE FOR EVALUATION SINCE THE DEVICE IS STILL IN TRANSIT. A FINAL REPORT WILL BE PROVIDED ONCE WE RECEIVE AND EVALUATE THE COMPLAINT DEVICE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THE INCIDENT. PHYSICIAN WAS ABLE TO COMPLETE THE SURGERY SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW-UP REPORT IN REFERENCE TO INITIAL MANUFACTURER REPORT NUMBER 1220948-2017-00069 THAT WAS SUBMITTED ON 12/8/2017. OUR INVESTIGATION ON THE COMPLAINT DEVICE DID NOT FIND ANY ISSUE WITH THE DEVICE. THE HOUSING AND THE POWER CORD WERE INSPECTED AND WERE FOUND TO BE ACCEPTABLE. DEVICE WAS FOUND TO BE OPERATING ON ALL SETTINGS AND FUNCTIONS. WE COULD NOT REPLICATE THE DEFECT AS DESCRIBED IN THE COMPLAINT DESCRIPTION. AT THIS TIME, WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE DEFECT SINCE THE DEVICE WAS FOUND TO BE OPERATIONAL.

    Description of Event or Problem · 1

    RESECTOR KEEPS SPINNING EVEN AFTER RELEASING THE BUTTON.

    Description of Event or Problem · 1

    RESECTOR KEEPS SPINNING EVEN AFTER RELEASING THE BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881482 TRIVEX SYSTEM RESECTOR HANDPIECE HANDPIECE DWQ LEMAITRE VASCULAR, INC. 00840663106561

    Patients

    Seq Age Sex Outcome Treatment
    1