BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2151867 · Received July 6, 2011

    Report

    Report Number
    3005099803-2011-02331
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: SERIAL NUMBER OF THE RETURNED DEVICE FOUND TO BE (B)(4). ADDITIONAL INFORMATION: DEVICE MANUFACTURED DATE IS (B)(6) 2006. VISUAL AND MECHANICAL EVALUATION FOUND THE FOOT SWITCH TO BE IN GOOD CONDITION. WHEN USED WITH THE RETURNED ENDOSTAT III GENERATOR, THE FOOT SWITCH PASSED THE ENDOSTAT III RETURN EVALUATION PROCEDURE. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE "CONSOLE INTERMITTENTLY LOSES POWER"; THE COMPLAINT WAS NOT CONFIRMED. THE DEVICE SHOWED NEITHER EVIDENCE OF THE ALLEGED ISSUE NOR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURED DATE IS UNKNOWN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, 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 # 3005099803-2011-02329 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 PROCEDURE (DATE AND TYPE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE USER WAS UNABLE TO ACHIEVE PROPER OUTPUT POWER IN MONOPOLAR MODES. NO ERROR CODES OR IMPEDANCE ISSUES WERE REPORTED, AND THE SYSTEM WAS TESTED FOLLOWING THE PROCEDURE AND NO ISSUES WERE FOUND. IT WAS CONFIRMED THAT THE USER ALLEGES NO MALFUNCTION OF THE ACTIVE CORD USED IN CONJUNCTION WITH THE ENDOSTAT AND FOOT SWITCH, AND IT HAS BEEN USED SUCCESSFULLY IN PROCEDURES SINCE THIS EVENT. IT WAS SUSPECTED THAT THE FOOT SWITCH BECAME LOOSE DURING USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02329 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 PROCEDURE (DATE AND TYPE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE USER WAS UNABLE TO ACHIEVE PROPER OUTPUT POWER IN MONOPOLAR MODES. NO ERROR CODES OR IMPEDANCE ISSUES WERE REPORTED, AND THE SYSTEM WAS TESTED FOLLOWING THE PROCEDURE AND NO ISSUES WERE FOUND. IT WAS CONFIRMED THAT THE USER ALLEGES NO MALFUNCTION OF THE ACTIVE CORD USED IN CONJUNCTION WITH THE ENDOSTAT AND FOOT SWITCH, AND IT HAS BEEN USED SUCCESSFULLY IN PROCEDURES SINCE THIS EVENT. IT WAS SUSPECTED THAT THE FOOT SWITCH BECAME LOOSE DURING USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540240

    Patients

    Seq Age Sex Outcome Treatment
    1