BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1901012 · Received November 17, 2010

    Report

    Report Number
    3005099803-2010-04826
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE WAS DISPOSED AND IS NOT AVAILABLE FOR RETURN. BASED ON THE DETAILS OF THE COMPLAINT, OPERATIONAL CONTEXT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT OF CLIP BENT AS A RESULT OF ANATOMICAL / PROCEDURE FACTORS ENCOUNTERED DURING THE PROCEDURE. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FOURTH OF FOUR COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #S 3005099803-2010-04823, 3005099803-2010-04824 AND 3005099803-2010-04825 FOR THE ASSOCIATED DEVICE REPORTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT FOUR RESOLUTION CLIPS WERE USED DURING A GASTROSCOPY PROCEDURE AT THE DUODENAL BULB ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS PRESENTED WITH BLACK FECES. DURING THE GASTROSCOPY PROCEDURE, THE NURSE REPORTED THAT THE CLIP DID NOT SAY ATTACHED TO THE TISSUE AFTER IT RELEASED FROM THE CATHETER. THE CLIP FELL OFF INSIDE THE PATIENT AND WAS LEFT TO PASS NATURALLY. ENDOSCOPIC VISUALIZATION REVEALED THAT THE PRONGS ON THE CLIP WERE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN "STABLE" CONDITION 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 10051802C2

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR