BEUDAMED
    FDA Adverse Event Summary report: N

    POLYLOOP

    MDR report key: 1020003 · Received March 18, 2008

    Report

    Report Number
    1020003
    Date Received
    March 18, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 18, 2008
    Manufacturer
    OLYMPUS AMERICA INC.
    Product Code
    MND
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    POLYLOOP INSERTED DOWN SCOPE AND WOULD NOT OPEN PROPERLY. THE DEVICE MALFUNCTIONED AND IT COULD NOT BE RELEASED. POLYLOOP FINALLY POPPED OPEN, AND APPEARED TO HAVE A TIP OR CAP ON THE END OF IT. LOOP WOULD NOT DEPLOY. REMOVED FROM SCOPE AND DISCARDED. POLYP INJECTED WITH 1CC EPINEPHRINE AND SALINE DUE TO HEMATOMA. PT. REMAINED STABLE AND NOW NEEDS TO COME BACK FOR POLYP REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYLOOP LIGATING DEVICE, ENDOSCOPIC MND OLYMPUS AMERICA INC. UNK 6K6031

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR