BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION STANDARD OVAL SNARE

    MDR report key: 1234043 · Received November 4, 2008

    Report

    Report Number
    3005099803-2008-05917
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POLYPECTOMY PROCEDURE, THE SNARE "BROKE." A SENSATION STANDARD OVAL SNARE HAD BEEN ADVANCED TO TREAT AN UNSPECIFIED POLYP. THE DEVICE "BROKE" DURING ELECTROCOAGULATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT'S CONDITION IS UNK. DESPITE MULTIPLE REQUESTS TO OBTAIN ADD'L INFO, NO INFO HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION STANDARD OVAL SNARE FDI BOSTON SCIENTIFIC M00562671 11808673

    Patients

    Seq Age Sex Outcome Treatment
    1