BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTATIC CLIPPING DEVICE

    MDR report key: 1133469 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03831
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    A HEMOSTATIC CLIPPING DEVICE WAS USED FOR AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE OF THE STOMACH IN 2008. ACCORDING TO THE COMPLAINANT, THE CLIP WOULD NOT DEPLOY FROM THE SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER HEMOSTATIC CLIPPING DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTATIC CLIPPING DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522612 0ML8042802

    Patients

    Seq Age Sex Outcome Treatment
    1