BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEM HANDLE

    MDR report key: 4795470 · Received May 26, 2015

    Report

    Report Number
    1722040-2015-00002
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    April 28, 2015
    Report Date
    May 1, 2015
    Manufacturer
    ENCISION INC.
    Product Code
    GEI
    PMA / PMN Number
    K912780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENCISION PERSONNEL TESTED THE DEVICES IN USE DURING THE REPORTED INCIDENT EVENT AT THE USER FACILITY ON MAY 7, 2015. THE DEVICES PERFORMED AS INTENDED AND SPECIFIED. DAMAGE TO THE OUTER INSULATION OF THE HANDLE SHAFT WAS OBSERVED. THE OBSERVED DAMAGE IS AN END OF LIFE INDICATOR FOR THE REUSABLE INSTRUMENT AND IS DESCRIBED IN THE INSTRUCTIONS FOR USE. TESTING CONFIRMED THAT THE ENCISION ACTIVE ELECTRODE MONITORING (AEM) SYSTEM, WHEN SET UP CORRECTLY WITH AN ELECTROSURGICAL GENERATOR AND A PATIENT RETURN ELECTRODE, PREVENTED ENERGY FROM BEING DELIVERED TO THE PATIENT THROUGH THE DAMAGED OUTER INSULATION. TESTING DID NOT IDENTIFY ANY DEVICE MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THE CAUSE OF THE REPORTED BURN COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    AN ENCISION INSTRUMENT WAS IN USE DURING AN EXPLORATORY LAPAROSCOPIC PROCEDURE AND EXICISION OF A UTERINE MASS DURING WHICH AN AREA OF THE FALLOPIAN TUBE WAS DAMAGED. THE USER REPORTED THAT THE DAMAGE DID NOT NEED ANY SURGICAL REPAIR OR ACTION. IT WAS ALSO REPORTED THAT THE PATIENT IS NOT OF CHILD BEARING AGE, SO THERE IS NO CONSEQUENCE AS A RESULT OF THE DAMAGE. THE SURGEON FOUND THE DAMAGE UPON INSPECTION AT THE END OF THE PROCEDURE. THE SURGEON DID NOT OBSERVE ANY ADDITIONAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340497 AEM HANDLE ELECTROSURGICAL ELECTRODE GEI ENCISION INC. ES8000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability EM2+ AEM MONITOR| ES0102 AEM DISPOSABLE CURVED SCISSORS, 3/4"| ES4107 AEM CORD, DISPOSABLE| VALLEYLAB FORCE TRIAD ELECTROSURGICAL GENERATOR