BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 2 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2103547 · Received May 26, 2011

    Report

    Report Number
    3005099803-2011-01779
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND MANY DECALS AND SCRATCHES ON THE COVER AND SIDES OF THE CHASSIS. ALL KNOBS AND SWITCHES FUNCTIONED PROPERLY. DURING ELECTRICAL EVALUATION, IT WAS FOUND THAT OUTPUT WAS HIGH IN THE MONOPOLAR "COAG" MODE, BUT ALL OTHER MODES PASSED THE ENDOSTAT II RETURN EVALUATION PROCEDURE. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE SYSTEM WOULD NOT DELIVER ENERGY; THE COMPLAINT WAS NOT CONFIRMED. ALTHOUGH THE UNIT'S OUTPUT WAS FOUND TO BE HIGH IN THE MONOPOLAR "COAG" MODE, 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) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    NEITHER OF THE FOOT SWITCHES USED DURING THIS PROCEDURE HAVE BEEN USED SINCE, NOR HAS THE ENDOSTAT II CONSOLE. A NON-BSC GENERATOR AND FOOT SWITCH WERE OBTAINED AND HAVE BEEN USED IN ALL SUBSEQUENT PROCEDURES. IT WAS ALSO CONFIRMED THAT A SNARE WAS USED DURING THIS PROCEDURE. NEITHER FOOT SWITCH SERIAL NUMBER IS KNOWN.

    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 THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-01780 AND 3005099803-2011-01914 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT AND TWO ENDOSTAT II FOOT SWITCHES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE SYSTEM WOULD NOT DELIVER ENERGY. THE FOOT SWITCH WAS REPLACED, WHICH TEMPORARILY RESOLVED THE ISSUE WITH POWER DELIVERY, BUT THE SYSTEM ONCE AGAIN FAILED TO DELIVER ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOSTAT II ELECTROSURGICAL UNIT AND FOOT SWITCH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-01780 AND 3005099803-2011-01914 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT AND TWO ENDOSTAT II FOOT SWITCHES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE SYSTEM WOULD NOT DELIVER ENERGY. THE FOOT SWITCH WAS REPLACED, WHICH TEMPORARILY RESOLVED THE ISSUE WITH POWER DELIVERY, BUT THE SYSTEM ONCE AGAIN FAILED TO DELIVER ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOSTAT II ELECTROSURGICAL UNIT AND FOOT SWITCH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-01780 AND 3005099803-2011-01914 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT AND TWO ENDOSTAT II FOOT SWITCHES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE SYSTEM WOULD NOT DELIVER ENERGY. THE FOOT SWITCH WAS REPLACED, WHICH TEMPORARILY RESOLVED THE ISSUE WITH POWER DELIVERY, BUT THE SYSTEM ONCE AGAIN FAILED TO DELIVER ENERGY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOSTAT II ELECTROSURGICAL UNIT AND FOOT SWITCH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    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