BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP

    MDR report key: 1170695 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04589
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE 2008 15-MONTH HEMOSTATIC CLIPPING DEVICE PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO REPORTED MALFUNCTIONS WHICH OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2008-04588 FOR DETAILS REGARDING THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT A RESOLUTION CLIP HEMOSTASIS DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE ATTEMPT TO DEPLOY THE RESOLUTION CLIP, "THE CLIP FELL OFF INSIDE THE PATIENT." IT WAS FURTHER REPORTED THAT "THE CLIP WAS LEFT TO PASS ON ITS OWN." THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8051406

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR