BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2202524 · Received August 11, 2011

    Report

    Report Number
    3005099803-2011-02737
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SEVEN DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02735, 3005099803-2011-002736, 3005099803-2011-02738, 3005099803-2011-02739, 3005099803-2011-02740 AND 3005099803-2011-02741 ADDRESSES THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SEVEN RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL SEVEN CLIPS GRASPED ONTO TISSUE HOWEVER, ALL SEVEN FAILED TO RELEASE FROM THE CATHETER. FIVE OF THE CLIPS WERE REMOVED WITH THE DELIVERY SYSTEM. TWO CLIPS FELL OFF WHEN THEY WERE BEING REMOVED AND FELL INTO THE PATIENT. THE TWO CLIPS WERE LEFT TO PASS NATURALLY. IT WAS REPORTED THAT THERE WAS NO TISSUE DAMAGE OR INCREASED BLEEDING AS A RESULT OF THIS EVENT. THE CASE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. 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 CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000022C2

    Patients

    Seq Age Sex Outcome Treatment
    1