BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1841070 · Received September 22, 2010

    Report

    Report Number
    3005099803-2010-04165
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS HOWEVER, AN EVALUATION HAS NOT BEEN PERFORMED AS OF YET. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS FULLY DEPLOYED AND THE PRONGS WERE BENT BACKWARDS. THE CONTROL WIRE WAS SEPARATED PER DESIGN. IN ADDITION, THERE WAS A KINK IN THE CONTROL WIRE NEAR THE HANDLE. THE ROOT CAUSE COULD NOT BE DETERMINED HOWEVER, THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE OPERATIONAL CONTEXT AS EVIDENT BY THE KINK IN THE CONTROL WIRE AND THE PRONGS BENT BACKWARDS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    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 3005099803-2010-04163 AND 3005099803-2010-04164 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RESOLUTION CLIP DEVICES WERE USED DURING A HEMOSTATIC CLIPPING IN THE RECTUM PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, IN ALL THREE INSTANCES, THE CLIPS WERE PLACED AT THE SITE HOWEVER; THE CLIPS SLIGHTLY OPENED AND FELL OFF THE TISSUE INSIDE THE PATIENT. IT HAS BEEN REPORTED THAT ALL THREE CLIPS WERE RETRIEVED WITH BIOPSY FORCEPS. 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 STABLE.

    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 3005099803-2010-04163 AND 3005099803-2010-04164 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE RESOLUTION CLIP DEVICES WERE USED DURING A HEMOSTATIC CLIPPING IN THE RECTUM PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, IN ALL THREE INSTANCES, THE CLIPS WERE PLACED AT THE SITE HOWEVER; THE CLIPS SLIGHTLY OPENED AND FELL OFF THE TISSUE INSIDE THE PATIENT. IT HAS BEEN REPORTED THAT ALL THREE CLIPS WERE RETRIEVED WITH BIOPSY FORCEPS. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR