BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEM FIXED TIP ELECTRODE, REUSABLE, L-WEDGE

    MDR report key: 1615594 · Received February 23, 2010

    Report

    Report Number
    1722040-2010-00001
    Event Type
    Other
    Date Received
    February 23, 2010
    Date of Event
    January 15, 2010
    Report Date
    February 15, 2010
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    PMA / PMN Number
    K912780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE ENCISION DEVICE HAS NOT BEEN RETURNED FOR EVAL. EVEN IF WITH NO MALFUNCTION IN EITHER DEVICE, IF THE SURGEON WAS IN CONTACT WITH BARE METAL ON THE COLD INSTRUMENT AND THE COLD INSTRUMENT CAME CLOSE ENOUGH FOR DIRECT OR CAPACITIVE COUPLING, HF ENERGY COULD BE TRANSMITTED TO THE SURGEON'S HAND. THE FIXED TIP ELECTRODE IFU STATES "DO NOT CONDUCT ENERGY BY TOUCHING AN AEM INSTRUMENT TO A SECOND INSTRUMENT CONTACTING TISSUE. THE SECOND DEVICE WILL NOT BE PROTECTED FROM CAPACITIVE COUPLING AND INSULATION FAILURE." NO PT INFO HAS BEEN SOLICITED BECAUSE THE INCIDENT DID NOT INJURE THE PT. THIS REPORT WILL BE UPDATED IF THE FIXED TIP ELECTRODE IS RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    SURGEON RECEIVED A BURN TO THE HAND DURING A LAP CHOLE. HE WAS HOLDING A COLD INSTRUMENT (SNOWDEN PENCER) AT ELECTRODE, WHEN IT CAME CLOSE TO THE ENERGIZED ENCISION FIXED TIP ELECTRODE. NO FAULT INDICATED TO FTE OR ENCISION SYSTEM. NO PT INJURY. NO MEDICAL INTERVENTION REQUIRED FOR THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM FIXED TIP ELECTRODE, REUSABLE, L-WEDGE LAPAROSCOPIC SURGICAL DEVICE GEI ENCISION, INC. ES3512B NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other