BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 3955340 · Received July 24, 2014

    Report

    Report Number
    3005099803-2014-02572
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED DEVICE FOUND MINIMAL SCRATCHES ON THE COVER. THE REST OF THE GENERATOR APPEARED TO BE IN GOOD CONDITION. FUNCTIONAL EVALUATION FOUND THAT ALL THE KNOBS AND SWITCHES FUNCTIONED PROPERLY HOWEVER, THE MONOPOLAR CONNECTOR WAS LOOSE AND NEEDED TO BE TIGHTENED . AN ELECTRICAL TEST WAS PERFORMED AND FOUND THAT DESPITE THE LOOSE MONOPOLAR CONNECTOR, THE UNIT PASSED THE ENDOSTAT III RETURN EVALUATION PROCEDURE AND WAS FOUND WITHIN ALL TEST PARAMETERS. THE COMPLAINT THAT THE DEVICE HAS INTERMITTENT POWER OUTPUT DURING MONOPOLAR COAGULATION MODE COULD NOT BE CONFIRMED. THE UNIT PASSED THE ENDOSTAT III RETURN EVALUATION PROCEDURE AND THE LOOSE MONOPOLAR CONNECTOR DID NOT APPEAR TO CONTRIBUTE TO THE REPORTED ISSUE. AFTER TIGHTENING THE MONOPOLAR CONNECTOR, THE UNIT PASSED THE FINAL TESTING. THE UNIT 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) CONFIRMED THAT NO DEVIATIONS WERE FOUND DURING ORIGINAL MANUFACTURING.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: GENERATOR OUTPUT ISSUES. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOSTAT III RF GENERATOR WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEVICE WOULD NOT CUT AND WAS ACTING SPORADICALLY. DETAILS ABOUT THE PROCEDURE AND PATIENT CONDITION WERE NOT AVAILABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOSTAT III RF GENERATOR WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEVICE WOULD NOT CUT AND WAS ACTING SPORADICALLY. DETAILS ABOUT THE PROCEDURE AND PATIENT CONDITION WERE NOT AVAILABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING 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
    433003 ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540200R0

    Patients

    Seq Age Sex Outcome Treatment
    1