BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1213106 · Received October 23, 2008

    Report

    Report Number
    3005099803-2008-05467
    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: 3005099803-2008-05469, 3005099803-2008-05470, 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 0ML7061403

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK