BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 2 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2122172 · Received June 13, 2011

    Report

    Report Number
    3005099803-2011-02052
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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: EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A PROCEDURE (DATE AND TYPE UNKNOWN). ACCORDING TO THE COMPLAINANT, IN THE MONOPOLAR "COAG" MODE THE OUTPUT POWER DROPPED FROM THE MAXIMUM SETTING AND THE UNIT BEGAN ALARMING. SWITCHING THE ACCESSORY DEVICE AND REBOOTING THE UNIT DID NOT RESOLVE THE ISSUE; THEREFORE THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOSTAT II ELECTROSURGICAL UNIT. FOLLOWING THE PROCEDURE THE BIOMED TESTED THE UNIT, AT WHICH TIME IT WORKED PROPERLY. IT IS UNKNOWN IF THE CABLE FAULT ALARM WAS ACTIVATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A PROCEDURE (DATE AND TYPE UNKNOWN). ACCORDING TO THE COMPLAINANT, IN THE MONOPOLAR "COAG" MODE THE OUTPUT POWER DROPPED FROM THE MAXIMUM SETTING AND THE UNIT BEGAN ALARMING. SWITCHING THE ACCESSORY DEVICE AND REBOOTING THE UNIT DID NOT RESOLVE THE ISSUE; THEREFORE THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOSTAT II ELECTROSURGICAL UNIT. FOLLOWING THE PROCEDURE THE BIOMED TESTED THE UNIT, AT WHICH TIME IT WORKED PROPERLY. IT IS UNKNOWN IF THE CABLE FAULT ALARM WAS ACTIVATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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