BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2093462 · Received May 18, 2011

    Report

    Report Number
    3005099803-2011-01785
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #'S 3005099803-2011-01784, 3005099803-2011-01785 AND 3005099803-2011-01786. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED IN THE COLON DURING A COLONOSCOPY PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-01784) WAS USED INSIDE THE PATIENT; HOWEVER, THE CLIP WAS FOUND TO BE BENT AND WOULD NOT CLOSE COMPLETELY OR PROPERLY. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT. THE SAME ISSUE OCCURRED FOR BOTH A SECOND AND THIRD DEVICE USED (MANUFACTURER REPORT #'S 3005099803-2011-01785 AND 3005099803-2011-01786). BOTH CLIPS WERE BENT AND WOULD NOT CLOSE COMPLETELY OR PROPERLY. THE PHYSICIAN REMOVED BOTH DEVICES FROM THE PATIENT AND ANOTHER RESOLUTION CLIP WAS USED TO COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO BE FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 11020202C2

    Patients

    Seq Age Sex Outcome Treatment
    1