BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 3922245 · Received July 9, 2014

    Report

    Report Number
    3005099803-2014-02516
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 12, 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 DISPLAYS ERROR MESSAGE. 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. ALL THE KNOBS AND SWITCHES APPEAR TO FUNCTION PROPERLY. ELECTRICAL EVALUATION WAS PERFORMED AND THE UNIT WAS FOUND TO BE WITHIN TEST PARAMETERS. CONNECTIONS INSIDE THE UNIT WERE CHECKED AND WIRES WERE MANIPULATED WHILE POWER WAS ACTIVATED IN BOTH MONOPOLAR AND BIPOLAR MODES, AND NO PROBLEMS WERE FOUND. THE COMPLAINT OF 'THE FAULT LIGHT OCCURRED, ISSUE APPEARS TO BE INTERMITTENT' WAS NOT CONFIRMED. THE RETURNED DEVICE SHOWED NEITHER EVIDENCE OF THE ALLEGED ISSUE, NOR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. A DHR REVIEW WAS PERFORMED AND NO DEVIATIONS WERE FOUND DURING ORIGINAL MANUFACTURING. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED SERIAL NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III RF GENERATOR WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE UNIT FAULT LIGHT CAME ON. THE DEVICE WAS REMOVED FROM THE ROOM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS CONFIRMED THAT THERE WAS NO HARM OR ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III RF GENERATOR WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE UNIT FAULT LIGHT CAME ON. THE DEVICE WAS REMOVED FROM THE ROOM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS CONFIRMED THAT THERE WAS NO HARM OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400567 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