BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EM2+ AEM MONITOR

    MDR report key: 2824769 · Received October 26, 2012

    Report

    Report Number
    1722040-2012-00005
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ENCISION INC
    Product Code
    GEI
    PMA / PMN Number
    K093622
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE APPLIED MEDICAL TROCAR IS PLASTIC, THE INSTRUMENTS USED HAD NO SIGNS OF DAMAGE, AND THE DESCRIPTION OF THE "BURN" IS NOT CONSISTENT THOSE LEFT BY RADIO-FREQUENCY-ENERGY, THE MANUFACTURER CONCLUDES THAT THE ELECTROSURGICAL-AEM SYSTEM DID NOT CONTRIBUTE TO OR CAUSE THE INJURY. THE LIKELY EXPLANATION FOR THE BURN-LIKE MARK WAS THAT IT WAS A CHEMICAL BURN LEFT WHEN CLEANING SOLUTIONS POOLED ON THE SKIN AROUND THE TROCAR SOMETIME BEFORE OR DURING THE PROCEDURE.

    Description of Event or Problem · 1

    UPON COMPLETION OF LAPAROSCOPIC HERNIA REPAIR, DOCTOR NOTICED A MARK THAT APPEARED LIKE A BURN ON THE SKIN AROUND ONE OF THE TROCARS. REQUIRED SOME ADDITIONAL SUTURING TO CLOSE. FACILITY ASSUMED THE MARK WAS AN ELECTROSURGICAL BURN, WHICH WAS NOT PREVENTED OR DETECTED BY THE ACTIVE-ELECTRODE MONITORING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EM2+ AEM MONITOR ELECTROSURGICAL ACCESSORY GEI ENCISION INC EM2+

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention APPLIED MEDICAL TROCAR| ES4007 HANDLE| ES0526 GRASPER/DISSECTER| CONMED SYSTEM 5000 ELECTROSURGICAL GENERATOR