BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1222891 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06129
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    DATE OF EVENT UNK. DURING THE UPPER GASTROINTESTINAL (GI) BLEED PROCEDURE, THE RESOLUTION CLIP WOULD NOT COME OUT OF THE SCOPE. THE SCOPE WAS NOT IN THE TORQUED POSITION. THE PHYSICIAN COMPLETED WITH ANOTHER OF THE SAME CLIP IN THAT SAME SCOPE WITH NO PROBLEM, NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522610 0ML7120602

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK