BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2250113 · Received September 15, 2011

    Report

    Report Number
    3005099803-2011-03175
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT CONFIRMED THAT THE ISSUE WAS NOT CAUSED BY THE ENDOSTAT III. RATHER, OTHER EQUIPMENT WAS FOUND TO HAVE CAUSED THE PROBLEM. THE COMPLAINANT NO LONGER ALLEGES A MALFUNCTION OF THIS DEVICE; THEREFORE, THIS IS NO LONGER CONSIDERED A REPORTABLE EVENT. DEVICE IS BEING RETAINED AT THE SITE FOR CONTINUED USE AND WILL NOT BE RETURNED FOR EVALUATION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT EMITTED AN ELECTRONIC BURN SMELL; THE BIOMED AT THE ACCOUNT SUSPECTED AN ELECTRICAL SHORT. IT IS UNKNOWN WHETHER THIS ISSUE OCCURRED DURING A PROCEDURE. 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 III ELECTROSURGICAL UNIT EMITTED AN ELECTRONIC BURN SMELL; THE BIOMED AT THE ACCOUNT SUSPECTED AN ELECTRICAL SHORT. IT IS UNKNOWN WHETHER THIS ISSUE OCCURRED DURING A PROCEDURE. 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 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540200

    Patients

    Seq Age Sex Outcome Treatment
    1