BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSE PROCEDURE

    MDR report key: 1031486 · Received April 1, 2008

    Report

    Report Number
    1031486
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 11, 2008
    Report Date
    April 1, 2008
    Manufacturer
    USGI MEDICAL
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS AN AGGREGATE OF THREE PROCEDURES: DEVICE LOOKS LIKE A LARGE ENDOSCOPE WITH FOUR INNER CHANNELS OR LUMENS. IN ONE CASE, A SCREW BROKE ON THE PLATFORM HOUSING. THERE WAS DIFFICULTY INSERTING THE GRASPERS DOWN THE CHANNEL AS THE DEVICE BECAME RIGID, AND THERE WAS A PROBLEM WITH THE MOVEABLE PARTS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROSE PROCEDURE ENDOSCOPE KOG USGI MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR
    2 39 YR
    3 68 YR