BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 2002805 · Received February 28, 2011

    Report

    Report Number
    3005099803-2011-00613
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. 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

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND SOME MINOR SCRATCHES ON THE CHASSIS; OTHERWISE THE UNIT APPEARED TO BE IN GOOD PHYSICAL CONDITION. ALL KNOBS AND SWITCHES FUNCTIONED PROPERLY. DURING ELECTRICAL EVALUATION, IT WAS FOUND THAT THE FOOT SWITCH IS NON-OPERATIONAL. THE FOOT SWITCH WAS REPLACED AND THE UNIT THEN PASSED THE ENDOSTAT II RETURN EVALUATION PROCEDURE. THE COMPLAINT THAT "THE UNIT FAILED TO DELIVER RF ENERGY" WAS CONFIRMED. THE MOST PROBABLE ROOT CAUSE OF THIS FAILURE IS ANOTHER DEVICE (I.E. THE FOOT SWITCH).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-00614, 3005099803-2011-00618, AND 3005099803-2011-00619 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT, AN ENDOSTAT II FOOT SWITCH, AN ACTIVE CORD, AND A SENSATION POLYPECTOMY SNARE WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, POWER DELIVERY TO THE SNARE COULD NOT BE ACHIEVED. THE FOOT SWITCH AND SNARE WERE REPLACED INDIVIDUALLY IN AN ATTEMPT TO IDENTIFY THE PROBLEMATIC SYSTEM COMPONENT; HOWEVER, THE ACTIVE CORD WAS NOT REPLACED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. FOLLOWING THE PROCEDURE, THE ACTIVE CORD WAS REPLACED, WHICH WAS REPORTED TO HAVE RESOLVED THE ISSUE WITH POWER DELIVERY, AND THIS ACTIVE CORD HAS BEEN USED SUCCESSFULLY SINCE THIS PROCEDURE. 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 FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-00614, 3005099803-2011-00618, AND 3005099803-2011-00619 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT, AN ENDOSTAT II FOOT SWITCH, AN ACTIVE CORD, AND A SENSATION POLYPECTOMY SNARE WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, POWER DELIVERY TO THE SNARE COULD NOT BE ACHIEVED. THE FOOT SWITCH AND SNARE WERE REPLACED INDIVIDUALLY IN AN ATTEMPT TO IDENTIFY THE PROBLEMATIC SYSTEM COMPONENT; HOWEVER, THE ACTIVE CORD WAS NOT REPLACED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. FOLLOWING THE PROCEDURE, THE ACTIVE CORD WAS REPLACED, WHICH WAS REPORTED TO HAVE RESOLVED THE ISSUE WITH POWER DELIVERY, AND THIS ACTIVE CORD HAS BEEN USED SUCCESSFULLY SINCE THIS PROCEDURE. 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