BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT II ELECTROSURGICAL UNIT

    MDR report key: 1160033 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04543
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURER DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS PLANNED FOR USE ON THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, THE FACILITY'S BIOMED DEPARTMENT NOTED THE ENDOSTAT CABLE WAS CUT IN TWO PIECES. IT WAS FURTHER REPORTED THAT AFTER SPLICING THE CUT ENDS TOGETHER, THE CABLE REMAINED NON-FUNCTIONAL. ADDITIONALLY, THE COMPLAINANT STATED THAT THE FOOTPEDAL SWITCH WAS "NOT CHANGING STATES." THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT II ELECTROSURGICAL UNIT KNS BOSTON SCIENTIFIC CORPORATION M0054080R0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1