BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION POLYPECTOMY SNARE

    MDR report key: 1193260 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05084
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED PROCEDURE, THE CLEAR POUCH OF THE SENSATION POLYPECTOMY SNARE HAD BEEN OPENED "AT THE BUTTON" AND THERE APPEARED TO BE NO SEAL TRACE ON THE POUCH AT THIS LOCATION. THE DEVICE WAS NOT USED AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION POLYPECTOMY SNARE FDI SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC M00560311

    Patients

    Seq Age Sex Outcome Treatment
    1