BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT III ELECTROSURGICAL UNIT

    MDR report key: 1438694 · Received May 6, 2009

    Report

    Report Number
    3005099803-2009-02264
    Event Type
    Malfunction
    Date Received
    May 6, 2009
    Report Date
    April 8, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    CONSOLE LOCKED UP. THE DEVICE HAS NOT BEEN REC'D FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT AN ENDOSTAT III ELECTROSURGICAL UNIT WAS USED DURING A ENDOSTAT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE IN COAG MODE, AFTER SETTING THE POWER BETWEEN 18-20, THE SYS WOULD IMMEDIATELY FREEZE UP AND SHOW 02 ON THE DISPLAY. THE CONSOLE POWER WOULD BE CYCLED, WHICH ALLOWED THE PROCEDURE TO BE CONTINUED. THE PROCEDURE WAS COMPLETED WITH THE SAME ENDOSTAT III ELECTROSURGICAL UNIT. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT III ELECTROSURGICAL UNIT KNS BOSTON SCIENTIFIC CORPORATION M00540200 0000005488

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK