BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 5000 ESU, ELECTROSURGICAL UNIT

    MDR report key: 5393897 · Received January 27, 2016

    Report

    Report Number
    1720159-2015-00006
    Event Type
    Injury
    Date Received
    January 27, 2016
    Date of Event
    November 2, 2015
    Report Date
    December 28, 2015
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K020186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONMED SYSTEM 5000 ELECTROSURGICAL UNIT WAS NOT RETURNED TO CONMED CORPORATION FOR EXAMINATION, EVALUATION, OR FAILURE ANALYSIS. DESPITE NUMEROUS COMMUNICATIONS SENT TO THE END-USER FACILITY THERE HAS BEEN NO RESPONSE RECEIVED TO ANY OF THE INQUIRIES AND THIS INCLUDES A CERTIFIED LETTER DATED 18-JAN-2016 AND WAS SIGNED FOR ON 25-JAN-2016. THIS DEVICE WAS WELL OVER 7 YEARS OLD AT THE TIME THE INCIDENT OCCURRED. ACCORDING TO THE SERVICE MANUAL FOR THE SYSTEM 5000 ELECTROSURGICAL UNIT, AN EIGHT-POSITION CONFIGURATION DIPSWITCH, LOCATED ON THE CONTROLLER PCB ASSEMBLY ALLOWS A QUALIFIED SERVICE TECHNICIAN TO CHANGE SOME OF THE FACTORY DEFAULT SETTINGS. THE FACTORY SETTINGS IS TO DEFAULT ALL MODES AND POWER LEVELS TO THE SETTINGS THE LAST TIME THE SYSTEM WAS POWERED DOWN. THUS, IF THE PREVIOUS MODE WAS SET AT "MACRO BIPOLAR", THAT WOULD BE THE SETTING ON STARTUP. PER NARRATIVE FROM THE END-USER FACILITY STAFF WITHIN THE MEDWATCH REPORT, THE ESU DOES NOT SOUND AS IF IT MALFUNCTIONED. THE NARRATIVE IN THE MEDWATCH REPORT APPEARS AS IF THE OPERATING ROOM STAFF ASSUMED THAT THE CONMED SYSTEM 5000 ESU BIPOLAR MODE DEFAULTS TO MICRO. IF THEY DID NOT ASSUME THIS THEN THE STAFF WOULD HAVE VERIFIED THE SETTINGS OF THE ESU PER THE IFU (INSTRUCTIONS FOR USE), OR, PER THEIR PROFESSIONAL STANDARDS OF PRACTICE. THE IFU OR OPERATING MANUAL FOR THE SYSTEM 5000 ESU STATES IN SECTION 1.1.3, CAUTIONS FOR USE, "CONFIRM THE DESIRED BIPOLAR MODE IS SELECTED PRIOR TO USE TO ENSURE OUTPUT CHARACTERISTICS ARE SUITABLE FOR THE INTENDED PROCEDURE." IF THE IFU WAS FOLLOWED THE BIPOLAR MODE SETTING WOULD HAVE BEEN VERIFIED BY OPERATING ROOM STAFF AS BEING IN THE MICRO MODE PRIOR TO OPERATION OF THE ESU. PROFESSIONAL STANDARDS OF PRACTICE ALSO ADDRESS THIS ISSUE FOR OPERATING ROOM STAFF REGARDING THE USE OF ELECTROSURGICAL EQUIPMENT. THE (B)(6), IN THEIR STANDARDS OF PRACTICE FOR USE OF ELECTROSURGERY, STANDARD OF PRACTICE IV, THE CST, CERTIFIED SURGICAL TECHNOLOGIST, SHOULD FOLLOW THE SAFETY PRINCIPLES FOR THE PROPER CARE AND HANDLING OF THE ELECTROSURGICAL UNIT (ESU) TO REDUCE THE PATIENT'S RISK FOR PERIOPERATIVE INJURIES. STATEMENT #7 WITHIN THIS STANDARD STATES, "THE CUT AND COAGULATION POWER SETTINGS WILL BE REQUESTED BY THE SURGEON AND SHOULD BE CONFIRMED PRIOR TO THE SKIN INCISION." REGARDING PERIOPERATIVE NURSES, THE AORN, ASSOCIATION OF PERIOPERATIVE REGISTERED NURSES, 2012 PERIOPERATIVE STANDARDS AND RECOMMENDED PRACTICES, RECOMMENDED PRACTICES FOR ELECTROSURGERY, RECOMMENDATION II, THE ESU SHOULD BE USED IN A MANNER THAT MINIMIZES THE POTENTIAL FOR INJURIES. SECTION II.F. STATES, "SETTINGS SHOULD BE BASED ON THE OPERATOR'S PREFERENCE CONSISTENT WITH THE INTENDED APPLICATION AND THE MANUFACTURER'S WRITTEN INSTRUCTIONS FOR PATIENT SIZE, ACTIVE ELECTRODE TYPE, AND RETURN ELECTRODE PLACEMENT. THE ESU'S POWER OUTPUT CAPABILITY IS DEPENDENT ON MULTIPLE VARIABLES RELATED TO THE PATIENT, GENERATOR, ACCESSORIES, AND THE PROCEDURE." SECTION II.F.1 OF THIS RECOMMENDATION STATES, "THE CIRCULATING NURSE SHOULD CONFIRM THE POWER SETTINGS WITH THE OPERATOR BEFORE ACTIVATION OF THE ESU." RECOMMENDATION OF THE AORN STANDARDS FOR ELECTROSURGERY, RECOMMENDATION XI, PERSONNEL INITIAL EDUCATION AND COMPETENCY VALIDATION, SECTION XI.B., STATES "PERSONNEL SHOULD BE INSTRUCTED ON THE PROPER OPERATION, CARE, AND HANDLING OF THE ESU AND ACCESSORIES BEFORE USE. INCORRECT USE CAN RESULT IN SERIOUS INJURY TO PATIENTS AND PERSONNEL." AGAIN IN THE ELECTROSURGICAL RECOMMENDATIONS, THE AORN STANDARDS, RECOMMENDATION XIII, POLICIES AND PROCEDURES FOR ELECTROSURGERY , POLICIES AND PROCEDURES ALSO SERVE AS OPERATIONAL GUIDELINES THAT ARE USED TO MINIMIZE PATIENT RISK FACTORS, STANDARDIZE PRACTICE, DIRECT STAFF MEMBERS, AND ESTABLISH GUIDELINES FOR CONTINUOUS PERFORMANCE IMPROVEMENT ACTIVITIES. SECTION XIII.B., STATES, "POLICIES AND PROCEDURES FOR ELECTROSURGERY SHOULD INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING: ... - EQUIPMENT CHECKS BEFORE INITIAL USE; ..." SUBSEQUENT TO THIS INCIDENT, THE USER FACILITY REPORTED THAT THE VENDOR WAS CONTACTED BY THE END-USER AND A VENDOR REPRESENTATIVE CAME INTO THE FACILITY AND PROVIDED IN-SERVICE WHICH INCLUDE REPROGRAMMING ALL OF THE ESU UNITS TO DEFAULT AUTOMATICALLY TO THE MICRO BIPOLAR SETTING. DUE TO UNANSWERED COMMUNICATIONS CONMED THEREFORE COULD NOT VERIFY WHO WAS THE "VENDOR REPRESENTATIVE" THAT REPORTEDLY WENT INTO THE END-USER FACILITY TO COMPLETE THE RE-PROGRAMMING OF THE ESU'S.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO CONMED CORPORATION. CONMED IS STILL ATTEMPTING TO GATHER FURTHER INFORMATION REGARDING THIS REPORTED EVENT. ON COMPLETION OF CONMED'S QUALITY ENGINEERING INVESTIGATION OF THIS REPORTED EVENT A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DURING A NEUROLOGICAL SURGICAL PROCEDURE THE END-USER WAS UTILIZING A 60-8005-001, SYSTEM 5000 ESU, ELECTROSURGICAL UNIT. A MEDWATCH WAS RECEIVED FROM THE FDA , REPORT NUMBER MW5058264, REGARDING THIS PROCEDURE AND READS, "AT THE TIME OF SURGERY AFTER REMOVAL OF THE SEGMENT AT C6, DURING BIPOLAR CAUTERIZATION OF AN EPIDURAL VEIN A SUDDEN CSF LEAK APPEARED. OPERATING MICROSCOPE WAS BROUGHT IN AND CLOSED THE DURA WITH 6-0 PROLENE. THEN, WHILE BIPOLAR CAUTERIZATION OF AN EPIDURAL VEIN AT C5, A SECOND CSF LEAK APPEARED. THIS OCCURRED WHILE USING THE MICROSCOPE AND VISUALIZED WHEN THE BIPOLAR WAS ACTIVATED A HOLE WAS CREATED. AT THIS POINT IT WAS DETERMINED THAT THE BIPOLAR UNIT WAS AT THE DEFAULT SETTING WHICH IS A MACRO SETTING. THE BIPOLAR UNIT WAS CHANGED TO MICRO FOR THE REST OF THE PROCEDURE. THIS PATIENT HAS REQUIRED 3 ADDITIONAL SURGERIES RELATED TO THE INITIAL INJURY DURING THE FIRST SURGERY. SURGERY #2 PRE OP DIAGNOSIS: LEAKING CERVICAL DUROTOMY REPAIR. POSTOP DIAGNOSIS: LEAKING CERVICAL DUROTOMY REPAIR. PROCEDURE: ATTEMPTED PLACEMENT OF LUMBAR CSF DIVERSION CATHETER. SURGERY #3 PRE OP DIAGNOSIS: CERVICAL WOUND CSF DRAINAGE. POSTOP DIAGNOSIS: CERVICAL WOUND CSF DRAINAGE. PROCEDURE: CERVICAL WOUND EXPLORATION TO RE-CLOSE THE DUROTOMY USING OPERATING MICROSCOPE. SURGERY #4 PRE OP DIAGNOSIS: CERVICAL WOUND DEHISCENCE. POSTOP DIAGNOSIS: CERVICAL WOUND DEHISCENCE. PROCEDURE: I & D OF CERVICAL WOUND WITH FULL THICKNESS EXCISIONAL DEBRIDEMENT DOWN TO BONY SPINAL CANAL. WOUND LEFT PACKED OPEN. THE DEFAULT SETTING FOR BIPOLAR ON THE CONMED 5000 IS MACRO. ALL STAFF IN THE OPERATING ROOM WERE SURVEYED ABOUT THIS, INCLUDING THE SURGEON AND NO STAFF WERE AWARE THAT THIS WAS THE DEFAULT SETTING. IN FACT, THEY HAD USED THIS MACHINE ON MULTIPLE OCCASIONS OVER THE YEARS AND HAVE NEVER CHANGED THE MICRO/MACRO BIPOLAR SETTING. OTHER BIPOLAR UNITS HAVE DEFAULT OF THE LOWEST SETTINGS RATHER THAN THE HIGHEST AS IS THE CASE WITH THIS DEVICE. THE VENDOR WAS CONTACTED AND HE CAME INTO THE FACILITY AND PROGRAMMED ALL OF THESE TYPE OF UNITS TO THE MICRO SETTING. " THIS DEVICE IS NOT AVAILABLE FOR RETURN. CONMED IS ATTEMPTING TO GATHER FURTHER INFORMATION RGARDING THIS REPORTED EVENT. TO DATE, NO INFORMATION HAS BEEN RECEIVED THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52297 SYSTEM 5000 ESU, ELECTROSURGICAL UNIT SYSTEM 5000 ESU GEI CONMED ELECTROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention