BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 1080674 · Received July 22, 2008

    Report

    Report Number
    3005099803-2008-01222
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED POLYPECTOMY PROCEDURE, A SNARE BREAK OCCURRED. THE LOCATION OF THE POLYP IS UNK. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE "SNARE BROKE". THE NATURE OF THE BREAK IS UNK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATABLE SNARE FDI SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC M00561831 11649791

    Patients

    Seq Age Sex Outcome Treatment
    1