BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYLOOP

    MDR report key: 1013892 · Received March 7, 2008

    Report

    Report Number
    1013892
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 7, 2008
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE OLYMPUS LOOP WAS PLACED INSIDE THE PATIENT. THE LOOP FRACTURED AS IT WAS ADVANCED IN THE NORMAL FASHION, AND IT BROKE OFF INTO THE PATIENT. THE DOCTOR WAS NOT PUSHING OR PULLING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYLOOP LIGATING DEVICE, ENDOSCOPIC MND OLYMPUS AMERICA, INC. * 7K6127

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR