BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 2132713 · Received June 17, 2011

    Report

    Report Number
    3005099803-2011-02055
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02056 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT AND AN ENDOSTAT III FOOT SWITCH WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, A PROBE WAS BEING USED TO RESOLVE MINOR BLEEDING FOLLOWING A SNARE POLYPECTOMY WHEN THE SYSTEM WOULD NOT DELIVER ENERGY ON ANY MODE. REPLACING THE PROBE DID NOT RESOLVE THE ISSUE, AND IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS TESTED WITH A PROBE THE FOLLOWING DAY AND FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT ELECTROSURGICAL UNIT UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540200

    Patients

    Seq Age Sex Outcome Treatment
    1