BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 3883473 · Received June 19, 2014

    Report

    Report Number
    3005099803-2014-02187
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    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

    REPORTED EVENT OF GENERATOR DISPLAYED ERROR MESSAGE. REPORTED EVENT OF GENERATOR EMITTED A BURNING SMELL. REPORTED EVENT OF FAILURE TO DELIVER CURRENT. 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

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE UNIT FOUND THE DEVICE IN GOOD CONDITION WITH SOME STICKERS ON THE COVER. FUNCTIONAL EVALUATION REVEALED THAT ALL THE KNOBS AND SWITCHES APPEAR TO FUNCTION PROPERLY. ELECTRICAL EVALUATION WAS PERFORMED AND THE UNIT WAS FOUND TO BE WITHIN TEST PARAMETERS. THE COMPLAINT OF ¿NO HEAT GENERATION TO THE SNARE, UNIT SMELLED BURNING AND SYSTEM FAULT LIT UP¿ WAS NOT CONFIRMED. THE RETURNED DEVICE PASSED ALL FINAL TESTING AND SHOWED NEITHER EVIDENCE OF THE ALLEGED ISSUES, NOR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. A DHR REVIEW WAS PERFORMED AND NO DEVIATIONS WERE FOUND DURING ORIGINAL MANUFACTURING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III RF GENERATOR WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE USER WAS ATTEMPTING TO ACTIVATE A SNARE, NO CURRENT WAS BEING GENERATED. THE GENERATOR WAS REPORTED TO BE SET ON THE MONOPOLAR: "COAG" MODE WITH A POWER OUTPUT OF 30 WATTS. A BURNING SMELL WAS THEN NOTICED TO BE COMING FROM THE GENERATOR; HOWEVER, NO SMOKE, SPARKS, OR FLAMES WERE SEEN. THE GENERATOR WAS STOPPED AND IMMEDIATELY REMOVED FROM SERVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOSTAT III RF GENERATOR. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III RF GENERATOR WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE USER WAS ATTEMPTING TO ACTIVATE A SNARE, NO CURRENT WAS BEING GENERATED. THE GENERATOR WAS REPORTED TO BE SET ON THE MONOPOLAR: "COAG" MODE WITH A POWER OUTPUT OF 30 WATTS. A BURNING SMELL WAS THEN NOTICED TO BE COMING FROM THE GENERATOR; HOWEVER, NO SMOKE, SPARKS, OR FLAMES WERE SEEN. THE GENERATOR WAS STOPPED AND IMMEDIATELY REMOVED FROM SERVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOSTAT III RF GENERATOR. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361526 ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540200

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR