BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EM2+ AEM MONITOR

    MDR report key: 6791298 · Received August 14, 2017

    Report

    Report Number
    1722040-2017-00001
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    June 21, 2017
    Report Date
    August 11, 2017
    Manufacturer
    ENCISION INC.
    Product Code
    GEI
    PMA / PMN Number
    K093622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EM2+ MONITOR AND ES3511B 35CM L-DIAMOND REUSABLE ELECTRODE HAVE NOT BEEN RETURNED TO ENCISION FOR TESTING. HOWEVER, A BIOMEDICAL TECHNICIAN AT THE REPORTING FACILITY PERFORMED TESTING RECOMMENDED BY ENCISION. THE TECHNICIAN PERFORMED THE FOLLOWING TESTS USING THE ENCISION EQUIPMENT ASSOCIATED WITH THE INCIDENT AND A VALLEYLAB FORCE-FX ELECTROSURGICAL UNIT: OPEN KEY TESTING FOR 10-15 SECONDS IN CUT AND COAG MODES, AT 30W AND 80W: NO ALARMS, NO DEFECTS. REPEAT OPEN KEY TESTING SUBSTITUTING THE INCIDENT INSTRUMENT WITH A KNOWN BAD TEST INSTRUMENT: MONITOR ALARMED IN ALL CASES, NO DEFECTS. REPEAT OPEN KEY TESTING WITH INCIDENT INSTRUMENT FOR SEVERAL SECONDS AT SEVERAL POWER SETTINGS TO OBSERVE FOR SHAFT HEATING: NO HEATING OBSERVED, NO DEFECTS. THE TEST RESULTS INDICATE NO PERFORMANCE ISSUES OR FAILURES OF THE INCIDENT ENCISION EM2+ MONITOR OR THE ES3511B L-DIAMOND ELECTRODE. BOTH THE MONITOR AND ELECTRODE EXHIBITED EXPECTED BEHAVIOR DURING TESTING PERFORMED BY THE BIOMEDICAL TECHNICIAN. THE ROOT CAUSE OF THE PROBLEM IS UNDETERMINED. ENCISION EXPLAINED TO THE REPORTING FACILITY PERSONNEL THAT ENCISION PRODUCTS ARE DESIGNED TO PREVENT STRAY ENERGY BURNS RESULTING FROM CAPACITIVE COUPLING OR INSULATION DAMAGE. BASED ON THE RESULTS OF THE TESTING, THERE IS NO INDICATION THAT THE INCIDENT MONITOR OR INSTRUMENT MALFUNCTIONED OR CAUSED OR CONTRIBUTED TO THE REPORTED BURN. NO FURTHER INVESTIGATION IS PLANNED AT THIS TIME UNLESS AND UNTIL ADDITIONAL INFORMATION IS PROVIDED BY THE REPORTING FACILITY OR THE INCIDENT ENCISION PRODUCTS ARE RETURNED FOR EXAMINATION. SEE MDR REPORT 1722040-2017-00002.

    Description of Event or Problem · 1

    MEDWATCH REPORT MW5070841 WAS RECEIVED FROM (B)(4) ON 17 JUL 2017 STATNG: "SURGEON USING CAUTERY FOR LAPAROSCOPIC PROCEDURE, CAUTERY MACHINE MISFIRED - POSSIBLE HOLE IN INSULATION. PATIENT RECEIVED BURN INTRA-ABDOMINALLY. BOTH MACHINE AND CAUTERY INSTRUMENT USED WERE TAGGED AND SENT TO BIOMED FOR EVALUATION." FROM SUBSEQUENT PHONE AND EMAIL CONTACTS WITH THE REPORTING FACILITY, THEIR RISK MANAGEMENT BELIEVES THAT THE EQUIPMENT DIDN'T SHUT DOWN LIKE IT NORMALLY WOULD. THEY SUSPECTED THE ENCISION AEM INSTRUMENT SHAFT INSULATION. THE ESU SETTING WAS 30W COAG, NO CUT. RISK MANAGEMENT STATED THAT THERE WAS NO ALARM TO INDICATE INSULATION FAILURE. MEDICAL INTERVENTION WAS NOT REQUIRED TO ADDRESS THE BURN, AS THE AREA THAT WAS AFFECTED WAS BEING REMOVED DURING THE PROCEDURE (LAP GASTRIC SLEEVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571463 EM2+ AEM MONITOR ELECTROSURGICAL ACCESSORY GEI ENCISION INC. EM2+

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other