BEUDAMED
    FDA Adverse Event Summary report: N

    SYSTEM 5000 ESU

    MDR report key: 3395490 · Received October 8, 2013

    Report

    Report Number
    1720159-2013-00089
    Date Received
    October 8, 2013
    Date of Event
    September 6, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K020186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION, THE SYSTEM 5000, IS AN ELECTROSURGICAL UNIT (ESU) THAT PROVIDES BOTH MONOPOLAR AND BIPOLAR MODES FOR USE IN A VARIETY OF PROCEDURES WHERE ELECTROSURGICAL CUTTING, AND/OR COAGULATION IS NEEDED. THE DEVICE WAS RETURNED TO CONMED CORPORATION FOR EVALUATION. ONE (1) SYSTEM 5000 ESU WAS RETURNED REGARDING A CUSTOMER COMPLAINT STATING THAT - SELF-ACTIVATED RESULTING IN AN INADVERTENT MINOR BURN TO PATIENT. THE RETURNED DEVICE WAS EXAMINED IN THE LABORATORY. NO FAULTS FOUND OR DAMAGE NOTED. UNIT WAS EVALUATED WITH THE RETURNED BIPOLAR FOOTSWITCH AND AN ETHICON INSTRUMENT (ETHICON ENDO-SURGERY ENDOPATH BIPOLAR FORCEPS REFERENCE NUMBER (B)(4), AND, BIPOLAR ADAPTOR LEAD/CABLE) AS UTILIZED IN THE REPORTED INCIDENT. THE SYSTEM 5000 ESU WAS COMPLETELY TESTED TO SPECIFICATIONS REGARDING THE FUNCTIONALITY AND SAFETY OF THE DEVICE. THE UNIT PASSED TESTING TO ALL TECHNICAL SPECIFICATIONS AND TO ALL SAFETY SPECIFICATIONS. DURING ALL TESTING PHASES THE UNIT DID NOT SELF-ACTIVATE AND FUNCTIONED AS EXPECTED. TESTING WAS UNABLE TO REPLICATE THE REPORTED INCIDENT. THE PROCEDURE BEING PERFORMED AT THE END-USER FACILITY WAS A LAPAROSCOPIC OVARIAN CYSTECTOMY. THE BURN TO THE PATIENT OCCURRED ON THE LOWER LEFT SIDE OF THE PATIENT'S ABDOMEN. THE BURN, REPORTED AS MINIMAL, WAS 7MM IN LENGTH, THE APPROXIMATE LENGTH OF THE ELECTROSURGICAL FORCEPS JAW (THE ACTIVE ELECTRODE OF THE DEVICE). THE CONMED SYSTEM 5000 ELECTROSURGICAL UNIT OPERATOR'S MANUAL STATES UNDER GENERAL CAUTIONS THAT, "SAFE AND EFFECTIVE ELECTROSURGERY IS DEPENDENT NOT ONLY ON EQUIPMENT DESIGN, BUT ALSO ON FACTORS UNDER THE CONTROL OF THE OPERATOR. IT IS IMPORTANT FOR THE INSTRUCTIONS SUPPLIED WITH THIS EQUIPMENT BE READ, UNDERSTOOD, AND FOLLOWED IN ORDER TO ENSURE THE SAFE AND EFFECTIVE USE OF THIS EQUIPMENT." THE OPERATOR'S MANUAL STATES IN SECTION 1.1.3, CAUTIONS FOR USE, TO, "ENSURE THAT THE FOOTSWITCHES ARE NOT INADVERTENTLY DEPRESSED IN ORDER TO PREVENT ACCESSORIES FROM BEING UNINTENTIONALLY ACTIVATED. PLACE FOOTSWITCHES IN LOCATIONS THAT NECESSITATE DELIBERATE ACTION IN ORDER TO ACTIVATE THE FOOTSWITCH." THE OPERATOR'S MANUAL ALSO STATES IN THIS SECTION THAT,"TEMPORARILY UNUSED ACTIVE ELECTRODES SHOULD BE STORED IN AN ELECTRICALLY INSULATED HOLSTER. THE UNUSED ACTIVE ELECTRODE SHOULD NEVER BE PLACED ON THE PATIENT. THIS IS ESPECIALLY IMPORTANT FOR LAPAROSCOPIC PROCEDURES." FOR THE PAST TWENTY YEARS THE (B)(4) INSTITUTE HAS WARNED USERS ABOUT PROBLEMS RELATED TO INADVERTENT ACTIVATION OF ELECTROSURGICAL UNIT (ESU) ACTIVE ELECTRODES. INADVERTENT ACTIVATION TYPICALLY OCCURS WHEN A SURGEON PLACES AN ESU ELECTRODE ON THE PATIENT OR SURGICAL DRAPES BETWEEN INTENDED ESU ACTIVATIONS AND A DEVICE MALFUNCTION OR UNINTENTIONAL SWITCH ACTIVATION CAUSE THE DEVICE TO BECOME ENERGIZED, RESULTING IN A BURN OR FIRE. TO AVOID AN INJURY OR INCIDENT THE (B)(4) INSTITUTE RECOMMENDS TO, "ALWAYS PLACED UNUSED ESU ACTIVE ELECTRODES IN A SAFETY HOLSTER. IF USING A HOLSTER IS INCONVENIENT OR AWKWARD (EG. WHEN USING ENDOSCOPIC ELECTROSURGICAL ELECTRODES), PLACE THE ELECTRODE AWAY FROM THE PATIENT AND SURGICAL DRAPES ON AN INSTRUMENT TRAY OR STAND; IF THIS IS NOT POSSIBLE, DISCONNECT THE ACTIVE ELECTRODE CABLE." (B)(4). BURNS AND FIRES FROM ELECTROSURGICAL ACTIVE ELECTRODE. 1993; 22(8-9): 421-422) THE (B)(4) PERIOPERATIVE STANDARDS AND RECOMMENDED PRACTICES, RECOMMENDED PRACTICES FOR ELECTROSURGERY, RECOMMENDATION VI, REITERATES THE (B)(4) INSTITUTE STATEMENT BY SAYING, "THE ACTIVE ELECTRODE SHOULD BE PLACED IN A CLEAN, DRY, WELL-INSULATED SAFETY HOLSTER WHEN NOT IN USE TO MINIMIZE THE RISK OF INJURY FROM UNINTENTIONAL ACTIVATION. INJURIES HAVE RESULTED WHEN THE ACTIVE ELECTRODE HAS BEEN LEFT LYING ON THE PATIENT BETWEEN USES. ELECTRODES THAT DO NOT FIT IN THE HOLSTER SHOULD BE PLACED IN A DESIGNATED LOCATION WITH TIPS AWAY FROM FLAMMABLE MATERIAL (EG. DRAPES)". THE COMPLAINT INVESTIGATION COULD NOT REPLICATE THE REPORTED INCIDENT. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED NOR CONFIRMED ANY MANUFACTURING DEFECTS ASSOCIATED WITH THIS INCIDENT; THEREFORE, CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CONMED THAT, "DIATHERMY REPORTED TO HAVE SELF-ACTIVATED RESULTING IN AN INADVERTENT MINOR BURN TO PATIENT DURING A LAPAROSCOPIC PROCEDURE. REPORTED AS SMALL MINOR BURN TO PATIENT. SITE OF BURN EXCISED AND STITCHED WITH A SINGLE 3/0 MONOCRYL SUTURE AND DRESSED WITH OPSITE DRESSING BY OPERATING THEATRE STAFF. DIATHERMY MACHINE AND ACCESSORIES REMOVED FROM USE AND QUARANTINED BY (B)(6) STAFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509714 SYSTEM 5000 ESU SYSTEM 5000 ESU GEI CONMED ELECTROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other