BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM CURVED SCISSOR INSERT

    MDR report key: 1918755 · Received November 15, 2010

    Report

    Report Number
    1918755
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    September 8, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ENCISION, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    SCISSORS TEAR TISSUE INSTEAD OF CUTTING TISSUE. SCISSORS ARE NEW AND THERE HAS BEEN MORE THAN 1 INCIDENT. WE HAVE NOTIFIED THE REP AND HE IS PICKING UP A PAIR OF THE SCISSORS TO SEND TO COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM CURVED SCISSOR INSERT LAPAROSCOPIC INSTRUMENT GEI ENCISION, INC * QEA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR