BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 2001625 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00513
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND DEVICE MANUFACTURED DATES ARE UNKNOWN.THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00512 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT AND A SENSATION POLYPECTOMY SNARE WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE OUTPUT POWER SEEMED TO BE ABOVE THE SET POINT. THE GENERATOR WAS IN THE MONOPOLAR "COAG" MODE SET TO 25 WATTS WHEN IT WAS REPORTED TO BE "RUNNING VERY HOT." THE PROCEDURE WAS COMPLETED WITH THE SAME ENDOSTAT III ELECTROSURGICAL UNIT AND SENSATION POLYPECTOMY SNARE. FOLLOWING THE PROCEDURE, THE SITE'S BIOMEDICAL ENGINEER PERFORMED A DIAGNOSTIC TEST ON THE UNIT AND CONFIRMED THAT OUTPUT ENERGY WAS HIGHER THAN USER SETTINGS, HOWEVER, SINCE THE POLYPECTOMY SNARE WAS DISCARDED, IT COULD NOT BE CONFIRMED WHETHER A MALFUNCTION OF THE SNARE HAD CONTRIBUTED TO THE EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA UNK657

    Patients

    Seq Age Sex Outcome Treatment
    1