BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 4242821 · Received November 11, 2014

    Report

    Report Number
    3005099803-2014-03594
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF FAILURE TO DELIVER ENERGY. REPORTED EVENT OF KNOB INTERMITTENTLY WORKING. 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 MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE UNIT RETURNED SHOWS MANY SCRATCHES ON THE COVER, ASIDE FROM THAT THE UNIT APPEARED TO BE IN GOOD PHYSICAL CONDITION. UPON FURTHER INSPECTION, IT WAS NOTED THAT THE POWER OUTPUT CONTROL KNOB WAS RUBBING AGAINST THE BEZEL MAKING IT HARD TO TURN. ONCE THE KNOB WAS ADJUSTED IT WORKED PROPERLY AND THE UNIT THEN PASSED THE ENDOSTAT III RETURN EVALUATION PROCEDURE. COMPLAINT CONFIRMED. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT POWER OUTPUT CONTROL KNOB WAS NOT WORKING. THE POWER OUTPUT CONTROL KNOB WAS RUBBING AGAINST THE BEZEL MAKING IT HARD TO TURN. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS WEAR AND TEAR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

    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) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE FUNCTIONS INTERMITTENTLY. THE MACHINE WAS SET UP TO WORK BUT ATTEMPTS TO DELIVER CAUTERY WERE UNSUCCESSFUL. THE SETTINGS WERE ADJUSTED PROPERLY AND THE GENERATOR MAKES THE APPROPRIATE SOUND, BUT IT WOULD NOT DELIVER CURRENT. IT WAS FOUND THAT WHEN THE WATTAGE DIAL IS QUICKLY TWISTED BACK AND FORTH FOR SEVERAL SECONDS AND THEN SET TO THE DESIRED WATTAGE THE GENERATOR WORKS AGAIN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS MALFUNCTION.

    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) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE FUNCTIONS INTERMITTENTLY. THE MACHINE WAS SET UP TO WORK BUT ATTEMPTS TO DELIVER CAUTERY WERE UNSUCCESSFUL. THE SETTINGS WERE ADJUSTED PROPERLY AND THE GENERATOR MAKES THE APPROPRIATE SOUND, BUT IT WOULD NOT DELIVER CURRENT. IT WAS FOUND THAT WHEN THE WATTAGE DIAL IS QUICKLY TWISTED BACK AND FORTH FOR SEVERAL SECONDS AND THEN SET TO THE DESIRED WATTAGE THE GENERATOR WORKS AGAIN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725638 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