BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM BIOPSY GU

    MDR report key: 3704888 · Received January 2, 2014

    Report

    Report Number
    1018233-2013-09742
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Report Date
    December 5, 2013
    Manufacturer
    LAVELLE MACHINE
    Product Code
    KNW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FIRES ON ITS OWN AFTER PRIMING WITHOUT TRIGGER BEING PULLED. THIS IS A REUSABLE DEVICE, HOWEVER, THIS EVENT OCCURRED OUTSIDE THE PT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3110 MAGNUM BIOPSY GU UNK KNW LAVELLE MACHINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1