BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEM SUCTION IRRIGATION ELECTRODE

    MDR report key: 2670576 · Received July 20, 2012

    Report

    Report Number
    1722040-2012-00003
    Event Type
    Injury
    Date Received
    July 20, 2012
    Date of Event
    May 25, 2010
    Report Date
    June 22, 2012
    Manufacturer
    ENCISION INC.
    Product Code
    GEI
    PMA / PMN Number
    K912780
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE CONTENTIONS OF "FACTS" EXPRESSED IN THE LEGAL FILING, INCLUDING WHETHER AN EVENT HAPPENED, CAN BE VERIFIED OR EVALUATED BY MANUFACTURER. MANUFACTURER HAS DETERMINED THAT NO COMMUNICATIONS CONCERNING THESE ALLEGED EVENTS WERE RECEIVED BY IT FROM ANY SOURCE AT ANY TIME UP UNTIL THE LEGAL FILING ARRIVED ON (B)(6) 2012.

    Description of Event or Problem · 1

    TEN DAYS FOLLOWING A PAIR OF SURGERIES BACK IN 2010 (THE TWO SURGERIES BEING FIVE DAYS APART), AN X-RAY OF PATIENT'S ABDOMEN REVEALED A LINEAR METALLIC FOREIGN OBJECT. THE PATIENT'S LAWYER CONTENTS, IN A LEGAL FILING, THAT THE OBJECT WAS A CAUTERY TIP BROKEN OFF FROM AN AEM SUCTION IRRIGATION ELECTRODE USED IN ONE OF THE SURGERIES. "AS A RESULT OF THE CAUTERY TIP BEING FOUND IN [PATIENT]'S ABDOMEN AND THE ADDITIONAL INFECTION, [PATIENT] WAS REQUIRED TO UNDERGO AT LEAST ONE ADDITIONAL SURGERY, CAUSING HER ADDITIONAL PAIN, INJURY, AND DISCOMFORT. [PATIENT] WAS ALSO HOSPITALIZED FOR A NUMBER OF WEEKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM SUCTION IRRIGATION ELECTRODE ELECTROSURGICAL ACTIVE ELECTRODE GEI ENCISION INC. ES3771-10 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention