BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION CRESCENT STANDARD SNARE

    MDR report key: 1213668 · Received October 23, 2008

    Report

    Report Number
    3005099803-2008-05464
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    July 17, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE HANDLE WAS FOUND SEPARATED AND CANNOT BE MOVED, THEREFORE, THE UNIT WILL NOT FUNCTION. DHR (DEVICE HISTORY RECORD) REVIEW PERFORMED AND NO DEVIATION WAS FOUND. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 9/29/2008. IT WAS REPORTED THAT WHILE UNPACKING FOR A POLYPECTOMY PROCEDURE, THE DEVICE HANDLE WAS MISSING. A MEDIUM STIFF STD CRESCENT SNARE HAD BEEN SELECTED. WHILE UNPACKING THE DEVICE IT WAS NOTICED THAT THE HANDLE WAS MISSING SO THE PRODUCT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THE HANDLE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION CRESCENT STANDARD SNARE FDI BOSTON SCIENTIFIC M00560331 8788229

    Patients

    Seq Age Sex Outcome Treatment
    1