BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1071615 · Received July 9, 2008

    Report

    Report Number
    3005099803-2008-01090
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GDO
    PMA / PMN Number
    K040148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE MANUFACTURE DATE CANNOT BE DETERMINED. THE SUSPECT DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION WAS NOT PERFORMED. THE CAUSE OF THE REPORTED MALFUNCTION CANNOT BE DETERMINED. THE MAY 2008 15-MONTH HEMOSTATIC CLIPPING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT #3005099803-2008-01092 FOR A DESCRIPTION OF THE SECOND EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 08, 2008 THAT A RESOLUTION CLIP DEVICE WAS USED IN AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, "BEFORE THE CLIP WAS INTRODUCED INTO THE SCOPE, THEY WERE UNABLE TO GET IT EXTENDED (OUT OF THE SHEATH). THE CLIP DETACHED AND INSIDE THE SHEATH." THE PHYSICIAN CONTINUED THE PROCEDURE WITH A SECOND RESOLUTION CLIP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE GDO BOSTON SCIENTIFIC CORPORATION M00522612 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention