BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1213104 · Received October 23, 2008

    Report

    Report Number
    3005099803-2008-05470
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. THE DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SEVEN DEVICES USED DURING THE PROCEDURE. REFER TO MFR REPORT#S: 3005099803-2008-05467, 3005099803-2008-05469, 3005099803-2008-05471, 3005099803-2008-05472, 3005099803-2008-05473 AND 3005099803-2008-05480 FOR DETAILS REGARDING THE ADDITIONAL SIX DEVICES. IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP HEMOSTASIS DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE, PERFORMED TWO DAYS PRIOR. ACCORDING TO THE COMPLAINANT, THE USER EXPERIENCED DIFFICULTY WITH DEPLOYING THE DEVICE ("DID NOT DEPLOY," "DEPLOYED PREMATURELY," OR "DID NOT PROPERLY HANG"). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522612 0ML7120612

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK