BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1063561 · Received June 20, 2008

    Report

    Report Number
    3005099803-2008-00879
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    A RESOLUTION CLIP DEVICE WAS USED TO CONTROL THE BLEEDING. THE PHYSICIAN FELT MORE FRICTION THAN USUAL DURING DETACHMENT OF THE CLIP. A FRAGMENT OF THE CLIP WAS DETACHED AND SEEN IN GASTROINTESTINAL (GI) TRACK, ON INSPECTION. THE BLEEDING WAS RESOLVED WITH THIS CLIP AND THE PROCEDURE WAS COMPLETED WITH NO PT INJURY. THE PT IS REPORTED TO BE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8030309

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK