BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3202750 · Received July 2, 2013

    Report

    Report Number
    3005099803-2013-05748
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS OVER 18 YEARS OLD. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. THE COMPLAINANT CONFIRMED THAT THE DEVICE WAS USED WITH A DUODENOSCOPE. THE RESOLUTION CLIP IS DESIGNED TO BE COMPATIBLE WITH GASTROSCOPES AND COLONOSCOPES WITH WORKING CHANNELS EQUAL TO OR GREATER THAN 2.8 MM. BASED ON THE DETAILS OF THE COMPLAINT, THE INVESTIGATION CONCLUDED THAT USER ERROR MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, AS THE PRODUCT WAS NOT RETURNED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF EIGHT DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2013-05732, 3005099803-2013-05742, 3005099803-2013-05743, 3005099803-2013-05744, 3005099803-2013-05747, 3005099803-2013-05748, 3005099803-2013-05749, & 3005099803-2013-05750 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT EIGHT RESOLUTION CLIP DEVICES WERE USED FOR HEMOSTASIS DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP "WOULD NOT OPEN PROPERLY OR DEPLOY WHEN NEEDED." THIS SAME ISSUE OCCURRED FOR A TOTAL OF EIGHT RESOLUTION CLIP DEVICES. HOWEVER, THEY WERE ABLE TO RELEASE THE EIGHTH RESOLUTION CLIP DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300996 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000438C3

    Patients

    Seq Age Sex Outcome Treatment
    1