BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 1914935 · Received December 6, 2010

    Report

    Report Number
    3005099803-2010-04997
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS AVAILABLE FOR EVALUATION AND WAS RETURNED (B)(6) 2010; THIS INFORMATION WAS OMITTED FROM THE PREVIOUS REPORT.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED UNIT FOUND CABLE TIE HOLDERS AFFIXED TO THE MACHINE ON THE COVER AND RIGHT SIDE OF THE CHASSIS, AS WELL AS MANY NON-M.S.I. DECALS ON THE COVER AND SIDES OF THE MACHINE. SOME MINOR SCRATCHES WERE ALSO FOUND ON THE COVER; OTHERWISE, THE UNIT APPEARED TO BE IN FAIR PHYSICAL CONDITION. A FUNCTIONAL EVALUATION WAS PERFORMED AND FOUND THAT ALL KNOBS AND SWITCHES APPEARED TO FUNCTION PROPERLY. ALTHOUGH THE UNIT REQUIRED CALIBRATION, NO PROBLEM WAS FOUND WITH THE DISPLAY. THE REPORTED COMPLAINT OF A DISPLAY ISSUE COULD NOT BE CONFIRMED. THE DISPLAY WAS CHECKED IN ALL MODES AND WAS WORKING PROPERLY. ALL CONNECTIONS INSIDE THE UNIT WERE CHECKED AND WIRES WERE MANIPULATED WHILE THE DISPLAY WAS BEING ADJUSTED AND NO PROBLEMS COULD BE FOUND WITH UNIT. ONCE THE UNIT WAS CALIBRATED, IT PASSED ALL FINAL TESTING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF LED DIGITAL DISPLAY WOULD NOT UPDATE. 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 AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THE CABLE FAULT ALARM WOULD NOT SHUT OFF IN MONOPOLAR "COAG" MODE. THE ACCOUNT NOTED THAT RESETTING THE UNIT FROM BIPOLAR MODE RESOLVED THE ISSUE WITH THE ALARM, BUT THE LED DIGITAL DISPLAY WOULD NOT UPDATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. AFTER THE PROCEDURE, THE NON-BSC PATIENT PLATE CORD USED IN THIS PROCEDURE WAS TESTED WITH A REPLACEMENT ENDOSTAT II ELECTROSURGICAL UNIT AND WAS FOUND TO BE DEFECTIVE, THUS CAUSING THE CABLE FAULT ALARM TO SOUND. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THE CABLE FAULT ALARM WOULD NOT SHUT OFF IN MONOPOLAR "COAG" MODE. THE ACCOUNT NOTED THAT RESETTING THE UNIT FROM BIPOLAR MODE RESOLVED THE ISSUE WITH THE ALARM, BUT THE LED DIGITAL DISPLAY WOULD NOT UPDATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. AFTER THE PROCEDURE, THE NON-BSC PATIENT PLATE CORD USED IN THIS PROCEDURE WAS TESTED WITH A REPLACEMENT ENDOSTAT II ELECTROSURGICAL UNIT AND WAS FOUND TO BE DEFECTIVE, THUS CAUSING THE CABLE FAULT ALARM TO SOUND. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THE CABLE FAULT ALARM WOULD NOT SHUT OFF IN MONOPOLAR "COAG" MODE. THE ACCOUNT NOTED THAT RESETTING THE UNIT FROM BIPOLAR MODE RESOLVED THE ISSUE WITH THE ALARM, BUT THE LED DIGITAL DISPLAY WOULD NOT UPDATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. AFTER THE PROCEDURE, THE NON-BSC PATIENT PLATE CORD USED IN THIS PROCEDURE WAS TESTED WITH A REPLACEMENT ENDOSTAT II ELECTROSURGICAL UNIT AND WAS FOUND TO BE DEFECTIVE, THUS CAUSING THE CABLE FAULT ALARM TO SOUND. 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 ELECTROSURGICAL UNIT UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M0054080R0

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR