BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 2 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2162746 · Received July 14, 2011

    Report

    Report Number
    3005099803-2011-02419
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CORRECTION: PATIENT WEIGHT WAS REPORTED TO BE (B)(6). THIS WAS OMITTED FROM THE PREVIOUS REPORT. CORRECTIONS: THE CAUTERY ISSUE WAS THOUGHT TO HAVE RESOLVED ITSELF PRIOR TO THIS PROCEDURE (SEE MANUFACTURER REPORT #S 3005099803-2011-02409 AND 3005099803-2011-02875). WHEN THE CAUTERY FAILURE OCCURRED, THE ENDOSTAT II ELECTROSURGICAL UNIT WAS REPLACED WITH A DIFFERENT GENERATOR, WHICH WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION: THE INVESTIGATION FOUND THAT THE ENDOSTAT FOOT SWITCH USED WITH THIS UNIT WAS DEFECTIVE. SEE MANUFACTURER REPORT # 3005099803-2011-02876. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND NON-MSI DECALS AND MINOR SCRATCHES ON THE COVER; OTHERWISE, THE UNIT APPEARED TO BE IN FAIR PHYSICAL CONDITION. ALL KNOBS AND SWITCHES FUNCTIONED PROPERLY. DURING ELECTRICAL EVALUATION IT WAS FOUND THAT THE IRRIGATION MODE DID NOT FUNCTION PROPERLY WITH THE FOOT SWITCH RETURNED WITH THE UNIT. FURTHER TESTING REVEALED THAT BOTH FOOT SWITCH PEDALS FUNCTIONED INTERMITTENTLY WHEN THE FOOT SWITCH CORD WAS MANIPULATED. THE FOOT SWITCH WAS REPLACED, AND THE UNIT THEN PASSED THE ENDOSTAT II RETURN EVALUATION PROCEDURE. THE COMPLAINT THAT THE SYSTEM DELIVERED ENERGY INTERMITTENTLY WAS CONFIRMED. ELECTRICAL EVALUATION FOUND THAT THE FOOT SWITCH HAD MALFUNCTIONED, THEREBY CAUSING INTERMITTENT OUTPUT FROM THE UNIT.

    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) 2011. ACCORDING TO THE COMPLAINANT, THE GENERATOR'S MONOPOLAR OUTPUT WAS INTERMITTENT. THE GROUNDING PADS, ACTIVE CORD, AND ACCESSORY DEVICE WERE ALL REPLACED BUT THE ISSUE PERSISTED. IT WAS REPORTED THAT THE ISSUE DID RESOLVE ON ITS OWN DURING THE PROCEDURE, HOWEVER, WHICH WAS COMPLETED SUCCESSFULLY USING THIS DEVICE. 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) 2011. ACCORDING TO THE COMPLAINANT, THE GENERATOR'S MONOPOLAR OUTPUT WAS INTERMITTENT. THE GROUNDING PADS, ACTIVE CORD, AND ACCESSORY DEVICE WERE ALL REPLACED BUT THE ISSUE PERSISTED. IT WAS REPORTED THAT THE ISSUE DID RESOLVE ON ITS OWN DURING THE PROCEDURE, HOWEVER, WHICH WAS COMPLETED SUCCESSFULLY USING THIS DEVICE. 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. THE INVESTIGATION FOUND THAT THE ENDOSTAT FOOT SWITCH RETURNED WITH THIS UNIT (SEE MANUFACTURER REPORT # 3005099803-2011-02876) WAS DEFECTIVE, AND NO ISSUES WERE FOUND WITH THE CONSOLE ITSELF. SINCE THE PROBLEMATIC SYSTEM COMPONENT WAS CONFIRMED TO BE THE FOOT SWITCH, THE ALLEGED EVENT REGARDING THE ENDOSTAT II ELECTROSURGICAL UNIT IS NO LONGER REPORTABLE.

    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 M0054080R0

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR