BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 3143052 · Received June 3, 2013

    Report

    Report Number
    3005099803-2013-04601
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: GENERATOR FAILED TO DELIVER ENERGY IN CUT AND COAG MODE. 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 ON (B)(4) 2013 THAT AN ENDOSTAT III RF GENERATOR WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH SPHINCTEROTOMY IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION OF THE PROCEDURE WAS BILE DUCT STONE REMOVAL. DURING THE PROCEDURE, THE GENERATOR FAILED TO DELIVER ENERGY IN THE ¿CUT¿ AND OR ¿COAG¿ MODES; IT IS UNKNOWN IF OTHER MODES FUNCTIONED PROPERLY. HOWEVER, IT WAS CONFIRMED THAT THE LIGHTS AND SOUNDS ON THE GENERATOR WERE WORKING PROPERLY. THE ACTIVE CORD, FOOT SWITCH, POWER CORD, GROUNDING PADS AND ACCESSORY DEVICE WERE ALL SWITCHED OUT AND THE GENERATOR STILL FAILED TO PRODUCE POWER IN THE ¿CUT¿ AND ¿COAG¿ MODES. ANOTHER UNIT WAS USED TO COMPLETE THE CASE. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT AN ENDOSTAT III RF GENERATOR WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH SPHINCTEROTOMY IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION OF THE PROCEDURE WAS BILE DUCT STONE REMOVAL. DURING THE PROCEDURE, THE GENERATOR FAILED TO DELIVER ENERGY IN THE ¿CUT¿ AND OR ¿COAG¿ MODES; IT IS UNKNOWN IF OTHER MODES FUNCTIONED PROPERLY. HOWEVER, IT WAS CONFIRMED THAT THE LIGHTS AND SOUNDS ON THE GENERATOR WERE WORKING PROPERLY. THE ACTIVE CORD, FOOT SWITCH, POWER CORD, GROUNDING PADS AND ACCESSORY DEVICE WERE ALL SWITCHED OUT AND THE GENERATOR STILL FAILED TO PRODUCE POWER IN THE ¿CUT¿ AND ¿COAG¿ MODES. ANOTHER UNIT WAS USED TO COMPLETE THE CASE. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE LIGHTS WERE ALL ON; HOWEVER THERE WAS NO POWER IN "CUT" AND "COAG" MODES. THE PROCEDURE WAS COMPLETED WITH ANOTHER COMPANY'S GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244446 ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540200R0

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR