BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1162843 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04604
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE ON THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, "DURING DEPLOYMENT, THE CLIP FAILED TO ROTATE AND RELEASE. THIS RESULTED IN A MUCOUS TEAR DURING REMOVAL OF THE DEVICE. TWO ADDITIONAL CLIPS WERE USED TO ACHIEVE HEMOSTASIS. THE PATIENT RECEIVED ANTIBIOTICS" (TYPE OF ANTIBIOTIC IS UNKNOWN) THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE 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 0ML7112609

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other