BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINA XCISE MORCELLATOR

    MDR report key: 2931742 · Received January 23, 2013

    Report

    Report Number
    2931742
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    September 27, 2012
    Report Date
    January 23, 2013
    Manufacturer
    LINA MEDICAL APS
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    STAFF OPENED THE DEVICE AND ATTEMPTED TO OPERATE THE DEVICE AND IT DID NOT WORK AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31864 LINA XCISE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET LINA MEDICAL APS MOR-1515 12224

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR