BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2974788 · Received February 22, 2013

    Report

    Report Number
    3005099803-2013-01042
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    February 11, 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. 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 COMPLAINT DEVICE FOUND THE UNIT TO BE IN GOOD CONDITION. ALL THE KNOBS AND SWITCHES APPEAR TO FUNCTION PROPERLY AND THE UNIT PASSED THE ENDOSTAT III RETURN EVALUATION PROCEDURE AND WAS WITHIN ALL TEST PARAMETERS. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT; THE COMPLAINT WAS NOT CONFIRMED. THE UNIT PASSED THE ENDOSTAT III RETURN EVALUATION PROCEDURE AND IS WITHIN ALL TEST PARAMETERS. ALL CONNECTIONS INSIDE THE UNIT WERE CHECKED AND WIRES WERE MANIPULATED WHILE THE RF WAS ACTIVATED IN ALL MODES AND NO PROBLEMS COULD BE FOUND WITH THE OUTPUT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) HEMOSTASIS PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE POWERED UP NORMALLY AND NO ABNORMAL SOUNDS WERE NOTED; HOWEVER, THE UNIT FAILED TO DELIVER ENERGY. THE GOLD PROBE WAS REPLACED, BUT THE SAME ISSUE WAS OBSERVED. THE PROCEDURE WAS COMPETED USING A SECOND ENDOSTAT III ELECTROSURGICAL UNIT. THE DEVICE HAS BEEN TESTED SINCE THIS INCIDENT AND IS VERY SLOW TO DELIVER ENERGY IN MONOPOLAR AND BIPOLAR MODES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) HEMOSTASIS PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE POWERED UP NORMALLY AND NO ABNORMAL SOUNDS WERE NOTED; HOWEVER, THE UNIT FAILED TO DELIVER ENERGY. THE GOLD PROBE WAS REPLACED, BUT THE SAME ISSUE WAS OBSERVED. THE PROCEDURE WAS COMPETED USING A SECOND ENDOSTAT III ELECTROSURGICAL UNIT. THE DEVICE HAS BEEN TESTED SINCE THIS INCIDENT AND IS VERY SLOW TO DELIVER ENERGY IN MONOPOLAR AND BIPOLAR MODES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78349 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