BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE RUNNING DEVICE

    MDR report key: 2070295 · Received April 13, 2011

    Report

    Report Number
    2070295
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 13, 2011
    Manufacturer
    LSI SOLUTIONS
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS DOING A LAPAROSCOPIC PROCEDURE AND WAS USING A RUNNING DEVICE FROM LSI. ACCORDING TO MD, THE DEVICE WAS MISFIRING. THE RUNNING DEVICE IS A SINGLE USE ITEM THAT ASSISTS WITH LAPAROSCOPIC SUTURING. THERE WAS NO PT HARM. THE DEVICE WAS GIVEN TO THE SALES REP TO RETURN TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE RUNNING DEVICE RUNNING DEVICE HCF LSI SOLUTIONS 021021 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *