BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 1962537 · Received January 18, 2011

    Report

    Report Number
    3005099803-2011-00073
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Report Date
    December 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR POLYPECTOMY SNARE WAS USED DURING A COLONOSCOPY PROCEDURE (PROCEDURE DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE SNARE WOULD NOT DELIVER ENERGY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BSC SNARE. THE FOOT PEDAL AND GENERATOR THAT WERE USED DURING THIS PROCEDURE HAVE BEEN USED SINCE WITH NO ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00561311 13685097

    Patients

    Seq Age Sex Outcome Treatment
    1