BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSTAT 2 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR

    MDR report key: 2232448 · Received September 2, 2011

    Report

    Report Number
    3005099803-2011-03028
    Event Type
    Injury
    Date Received
    September 2, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A PROCEDURE (NAME AND DATE PERFORMED UNKNOWN). ACCORDING TO THE COMPLAINANT, THE GENERATOR'S ENERGY DELIVERY WAS VERY WEAK. THE USER WAS ATTEMPTING TO PERFORM A CUT, BUT THE INSUFFICIENT ENERGY RESULTED IN MINOR PATIENT BLEEDING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GENERATOR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING 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 M00540800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention