BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2031123 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-00913
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE THIRD OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #'S 3005099803-2011-00911 AND 3005099803-2011-00912 FOR THE ASSOCIATED DEVICE REPORTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE WITH ENDOSCOPIC MUCOSAL RESECTION (EMR) TO TREAT A RESECTION DEFECT ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST RESOLUTION CLIP WAS ADVANCED DOWN THE COLONOSCOPE; HOWEVER, THE DEVICE WOULD NOT EXIT FROM THE END OF THE SCOPE AND INTO THE PATIENT. THE CLIP WAS REMOVED FROM THE PATIENT AND UPON EXAMINATION, IT WAS NOTICED THAT THE ONE OF THE PRONGS ON THE CLIP WAS BENT AND THE CLIP ASSEMBLY APPEARED TO BE SLIGHTLY BENT AS WELL. THE SAME ISSUE OCCURRED FOR A SECOND AND THIRD RESOLUTION CLIP USED; BOTH DEVICES WOULD NOT EXIT FROM THE END OF THE SCOPE AND UPON EXAMINATION OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE CLIPS WERE BENT. ALTHOUGH HEMOCLIP SHEATHS ARE NOT INTENDED FOR REMOVAL, CLINICAL FOLLOW UP REVEALED THAT ALL THREE OVER SHEATHS WERE REMOVED FROM THE DEVICES PRIOR TO USE THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS USING SEVERAL RESOLUTION CLIPS AND 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 10120603C2

    Patients

    Seq Age Sex Outcome Treatment
    1