BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1193358 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05124
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE DEVICE HAS BEEN DISCARDED. A DEVICE EVAL IS NOT AVAILABLE; THEREFORE, THE CAUSE OF THE REPORTED ISSUE IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO FIRST OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2008-05123 FOR A DESCRIPTION OF THE OTHER EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED SIX DAYS PRIOR. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, "THE SCOPE WAS IN A VERY TORTUOUS POSITION AND THE [CLIP WOULD] NOT COME OUT OF THE SHEATH." THE PHYSICIAN ATTEMPTED TO COMPLETE THE PROCEDURE WITH A SECOND RESOLUTION CLIP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML7032405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK