BEUDAMED
    FDA Adverse Event Other Summary report: N

    5MM AEM HANDLE ASSEMBLY

    MDR report key: 728664 · Received June 22, 2006

    Report

    Report Number
    1722040-2006-00004
    Event Type
    Other
    Date Received
    June 22, 2006
    Report Date
    June 15, 2006
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ELECTROSURGICAL HANDLE WAS VISUALLY INSPECTED AND ELECTRICALLY TESTED. THE INSERT IN USE FOR THE PROCEDURE, A REUSABLE SCISSORS, WAS NOT RETURNED FOR EVALUATION. THE HANDLE PASSED ELECTRICAL TESTING FOR CONTINUITY, ELECTRICAL SAFETY AND INSULATION INTEGRITY. CAPACITIVE COUPLING CAN OCCUR WITH AN INTACT INSTRUMENT IF THE AEM MONITOR IS NOT SETUP PROPERLY.HOWEVER, THE HOSP SUPPLIED A PHOTO OF THE BURN AREA, WHICH DID NOT SHOW TISSUE DAMAGE CONSISTENT WITH CAPACITIVE COU;ING. IN ADDITION, VISUAL INSPECTION OF THE SHAFT OF THE INSTRUMENT DID NOT SHOW ANY INDICATION OF ARCING OF THE ACTIVATED TIP WITH UNTINTENDED TISSUE. IF UNDETECTED THIS CAN CAUSE SERIOUS COMPLICATIONS. INSTRUCTIONS FOR USE STATES THE SURGEON SHOULD MAINTAIN THE AREA OF TIP IN HIS/HER FIELD OF VIEW. THE DEVICE WAS RETURNED TO THE CUSTOMER, SINCE IT WAS FUNCTIONING PROPERLY, INCLUDING THE AEM CIRCUIT.

    Description of Event or Problem · 1

    PHYSICIAN PERFORMING LIGAMENT SURGERY AT UTERUS OBSERVED AT THE END OF THE PROCEDURE THAT THERE WAS A BURN ON TH EUTERUS ABOUT 1.1/2" FROM THE AREA THAT THEY WERE WORKING. INJURY WAS REPORTED AS MINOR, WITH NO PT ACTIONS CONDUCTED. DEVICE WAS RETURNED TO MFR FOR EVALUATION OF AEM ALARM FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM AEM HANDLE ASSEMBLY LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES8000 KIA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other