BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 2 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2231811 · Received September 1, 2011

    Report

    Report Number
    3005099803-2011-02986
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND STICKER RESIDUE AND SOME MINOR SCRATCHES ON THE COVER. ALL KNOBS AND SWITCHES FUNCTIONED PROPERLY DURING MECHANICAL EVALUATION. DURING ELECTRICAL TESTING, HOWEVER, IT WAS FOUND THAT THE PUMP MOTOR WAS NOT FUNCTIONING, THUS PREVENTING IRRIGATION. THE MOTOR WAS REPLACED, AFTER WHICH THE UNIT FUNCTIONED PROPERLY.THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE "PUMP IS FAILING"; THE COMPLAINT WAS CONFIRMED. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS WEAR AND TEAR.A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED SERIAL NUMBER.

    Additional Manufacturer Narrative · 1

    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 # 3005099803-2011-02987 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT AND AN ENDOSTAT II FOOT SWITCH WERE USED DURING A PROCEDURE (DATE PERFORMED AND TYPE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE IRRIGATION PUMP CIRCULATED FLUID MUCH SLOWER THAN WAS DESIRED; HOWEVER, THE PROCEDURE WAS COMPLETED WITH THE SAME ENDOSTAT II ELECTROSURGICAL UNIT AND FOOT SWITCH. A MANUAL IRRIGATION METHOD WAS EMPLOYED INSTEAD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02987 ADDRESSES THE OTHER DEVICE.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT AND AN ENDOSTAT II FOOT SWITCH WERE USED DURING A PROCEDURE (DATE PERFORMED AND TYPE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE IRRIGATION PUMP CIRCULATED FLUID MUCH SLOWER THAN WAS DESIRED; HOWEVER, THE PROCEDURE WAS COMPLETED WITH THE SAME ENDOSTAT II ELECTROSURGICAL UNIT AND FOOT SWITCH. A MANUAL IRRIGATION METHOD WAS EMPLOYED INSTEAD.ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT 2 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540800

    Patients

    Seq Age Sex Outcome Treatment
    1