BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP

    MDR report key: 3040002 · Received April 2, 2013

    Report

    Report Number
    MW5029603
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT COLONOSCOPY WITH HOT SNARE POLYPECTOMY AND CLIP PLACEMENT. FOLLOWING THE POLYPECTOMY, TWO CLIPS WERE PLACED AT THE SITE FOR HEMOSTASIS. DURING THE CLIP PLACEMENT, THE FIRST CLIP DID NOT ATTACH TO THE LUMEN WALL. THE SITE WAS INSPECTED AND IT WAS NOTED THAT THE CLIP HAD BROKEN INTO TWO PIECES. THE CLIP WAS RETRIEVED AND REMOVED FROM THE PT AND A NEW CLIP WAS PLACED. THE PROCEDURE SCOPE WAS WITHDRAWN FROM THE PT AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133727 RESOLUTION CLIP ENDOSCOPY CLIP KOG BOSTON SCIENTIFIC 2261 ML00439C3

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention