BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 3192358 · Received June 27, 2013

    Report

    Report Number
    3005099803-2013-06122
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: INTERMITTENT ENERGY DELIVERY. 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.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE COVER TO HAVE A FEW MINOR SCRATCHES. FUNCTIONAL EVALUATION WAS PERFORMED AND ALL THE KNOBS AND SWITCHES APPEAR TO FUNCTION PROPERLY. HOWEVER, THE ACTIVE CORD CONNECTOR SEEMS TO BE CONNECTED LOOSELY TO ITS MATING CONNECTOR. IN ORDER TO TEST THE MONOPOLAR OUTPUT, THE ACTIVE CONNECTOR HAD TO BE HELD IN CONTACT WITH ITS MATE. THE ACTIVE CONNECTOR WAS REPLACED AND THEN THE UNIT PASSED THE ENDOSTAT III RETURN EVALUATION PROCEDURE AND IS WITHIN ALL TEST PARAMETERS. THE COMPLAINT WAS CONFIRMED. THE MOST PROBABLE ROOT CAUSE IS WEAR AND TEAR DUE TO LONG OR EXTENDED USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III RF GENERATOR WAS USED DURING A PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS GENERATOR; HOWEVER ENERGY WAS BEING DELIVERED INTERMITTENTLY IN MONOPOLAR COAG MODE TO THE ACCESSORY DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION: THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III RF GENERATOR WAS USED DURING A PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS GENERATOR; HOWEVER ENERGY WAS BEING DELIVERED INTERMITTENTLY IN MONOPOLAR COAG MODE TO THE ACCESSORY DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III RF GENERATOR WAS USED DURING A PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS GENERATOR; HOWEVER ENERGY WAS BEING DELIVERED INTERMITTENTLY IN MONOPOLAR COAG MODE TO THE ACCESSORY DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION: THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292492 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