BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATION POLYPECTOMY SNARE

    MDR report key: 1163569 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04601
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. NO UNFAVORABLE TREND HAS BEEN FOUND FOR THIS TYPE OF MALFUNCTION. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POLYPECTOMY PROCEDURE, CUTTING DIFFICULTIES WERE ENCOUNTERED. THE POLYP WAS LOCATED IN THE STOMACH. THE SENSATION MICRO OVAL POLYPECTOMY SNARE WAS ADVANCED TO THE POLYP, HOWEVER, UPON ATTEMPTING TO REMOVE THE POLYP THE SNARE WAS UNABLE TO MAKE A CLEAN CUT AND TORE THE PATIENT'S TISSUE. THE PHYSICIAN APPLIED A NEW CAUTERY CORD, HOWEVER, THE SAME PROBLEM OCCURRED. IT WAS NOTED THAT THERE WAS NO BLEEDING. NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION POLYPECTOMY SNARE FDI SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC M00562693 0011720515

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ERBE GENERATOR