BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1991078 · Received February 15, 2011

    Report

    Report Number
    3005099803-2011-00291
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE SUSPECT DEVICE COULD NOT BE PERFORMED AS THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. BASED ON THE DETAILS OF THE COMPLAINT, IS IT PROBABLE THAT ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE RESULTED IN THE CLIP BREAKING; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A RESOLUTION HEMOSTASIS CLIPPING DEVICE WAS USED TO TREAT A POST-POLYPECTOMY BLEED IN THE COLON DURING A COLONOSCOPY PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE COLONOSCOPY PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY A RESOLUTION CLIP ONTO THE TARGET TISSUE TO RESOLVE A SUBSEQUENT BLEED; HOWEVER, THE CLIP BROKE AT THE JOINT. THE DEVICE WAS RETRIEVED FROM THE PATIENT AND THE BLEED WAS SUCCESSFULLY RESOLVED WITH ANOTHER MANUFACTURER'S CAUTERY UNIT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT WAS REPORTED TO BE FINE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10042102C2

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR