BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1082532 · Received July 22, 2008

    Report

    Report Number
    3005099803-2008-01224
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE MANUFACTURE DATE CANNOT BE DETERMINED. THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE MAY 2008 15-MONTH HEMOSTATIC CLIPPING PRODUCT FAMILY COMPLAINT TREND REPORT HAS BEEN REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    ON JUNE 23, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION HEMOSTASIS CLIPPING DEVICE WAS USED IN A GASTRIC BLEED PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, "DURING THE PROCEDURE, THE CLIP BENT BACKWARDS. WHEN THE CLIP WAS PUSHED AGAINST THE TISSUE IT BENT BACKWARDS." THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND RESOLUTION HEMOSTASIS CLIPPING DEVICE. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE KOD BOSTON SCIENTIFIC CORPORATION M00522610 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK