BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION POLYPECTOMY SNARE

    MDR report key: 1181513 · Received September 25, 2008

    Report

    Report Number
    3005099803-2008-04752
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE WOULD NOT BE COMPLETED. A DEVICE HISTORY REVIEW (DHR) COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNK. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLONOSCOPY PROCEDURE, THE DEVICE MADE AN ABNORMAL NOISE AND WAS UNABLE TO CUT. THE LESION WAS LOCATED IN AN UNSPECIFIED PORTION OF THE COLON. THE SENSATION MICRO OVAL POLYPECTOMY SNARE WAS ADVANCED TO THE LESION. UPON ATTEMPTING TO USE THE DEVICE, THE DEVICE MADE A "CLICKING SOUND" AND WAS UNABLE TO CUT THE POLYP. IT WAS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION POLYPECTOMY SNARE SENSATION POLYPECTOMY SNARE FDI BOSTON SCIENTIFIC M00562693

    Patients

    Seq Age Sex Outcome Treatment
    1