BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1062305 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00740
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IN EFFORT OF PUSHING THE RESOLUTION CLIP DEVICE OUT DURING THE COLONOSCOPY PROCEDURE, THE CLIP DEPLOYED IN THE SHEATH OF THE SCOPE. THE SECOND CLIP ALSO FAILED. THE CASE WAS NOT COMPLETED DUE TO THE EVENT. THE PT REPORTED TO BE "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522610 0ML7092604

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK