BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACROLYTE DISPERSIVE ELECTRODE, PEDIATRIC SINGLE DISPERSIVE WITH 10 FOOT CABLE

    MDR report key: 2941214 · Received February 4, 2013

    Report

    Report Number
    3007305485-2013-00012
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 10, 2013
    Report Date
    April 19, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K120476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING HELD BY RISK MANAGEMENT DEPARTMENT OF END-USER FACILITY. CONMED IS ATTEMPTING TO RECOVER THE DISPERSIVE ELECTRODE DEVICE SO A ENGINEERING INVESTIGATION CAN BE COMPLETED. ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE BEING HELD BY END-USER RISK DEPT.

    Additional Manufacturer Narrative · 1

    CONMED MACROLYTE DISPERSIVE ELECTRODES ARE DESIGNED FOR USE WITH ELECTROSURGICAL GENERATORS DURING ELECTROSURGERY AND PROVIDE A PATH FOR RF ENERGY PRODUCED AT THE ACTIVE ELECTRODE TO RETURN TO THE GENERATOR. THE CONMED MACROLYTE DISPERSIVE ELECTRODE IS FOR USE WITH ALL PATIENT POPULATIONS PROVIDING THERE IS SUFFICIENT SURFACE AREA TO ENSURE FULL CONTACT OF THE ELECTRODE WITH THE PATIENT'S SKIN. A DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW WAS NOT ACCOMPLISHED FOR THE LOT NUMBER WAS NOT AVAILABLE. NO LABORATORY EXAMINATION WAS PERFORMED ON THE COMPLAINT PRODUCT, AS NO DEVICE WAS RETURNED TO CONMED FOR EXAMINATION OR CONFIRMATION OF DEFECT OR CONFIRMATION OF CONMED PRODUCT. THERE MAY BE A MULTIPLE OF POSSIBLE CAUSES EITHER MANUFACTURING OR USER RELATED. THE COMPLAINT CAN BE NEITHER CONFIRMED NOR UNCONFIRMED AT THIS TIME. POSSIBLE CAUSE FOR THIS FAILURE MODE COULD BE IMPROPER PAD SITE PREPARATION PRIOR TO APPLICATION OF THE DISPERSIVE ELECTRODE. THE IFU, INSTRUCTIONS FOR USE, SPECIFIES, "PREPARE THE SKIN AT THE APPLICATION SITE ACCORDING TO FACILITY PROTOCOL. IF NO PROTOCOL EXISTS, CLIP EXCESS HAIR AT APPLICATION SITE, CLEAN AND DISINFECT AREA TO REMOVE OILS, LOTIONS, ETC., AND ALLOW TO DRY THOROUGHLY". ANOTHER POSSIBLE CAUSE FOR THIS FAILURE MODE COULD BE THE INABILITY TO ACHIEVE GOOD PAD ADHESION TO THE PATIENT SKIN. THE IFU ALSO SPECIFIES TO, "APPLY ELECTRODE FIRMLY ENSURING FULL ADHESION AND CONTACT WITH THE PATIENT'S SKIN". THE IFU WARNS THE END-USER THAT, "FAILURE TO ACHIEVE GOOD SKIN CONTACT BY THE ENTIRE ADHESIVE SURFACE OF THE DISPERSIVE ELECTRODE MAY RESULT IN ELECTROSURGICAL BURNS OR POOR ELECTROSURGICAL PERFORMANCE". IN ADDITION THE IFU PROVIDES PROPER POWER SETTINGS AND ACTIVATION TIMES IN ORDER TO MINIMIZE THE POTENTIAL FOR PATIENT BURNS. DURING THE INVESTIGATION OF THIS COMPLAINT IT WAS DISCOVERED THAT THIS PATIENT'S WEIGHT WAS (B)(6). THE WEIGHT THRESHOLD STANDARDS HAVE BEEN REVISED AND THE CURRENT RECOMMENDED WEIGHT RANGE FOR THIS DISPERSIVE ELECTRODE IS 5-15KG. AN ADULT DISPERSIVE ELECTRODE WOULD HAVE BEEN RECOMMENDED FOR THIS PATIENT WITH A CURRENT WEIGHT USAGE FOR PATIENTS >15KG. HOWEVER, THE PREVIOUS ISO ELECTRIC STANDARDS ALLOWED THE USAGE OF THIS DISPERSIVE ELECTRODE IN THE PATIENT POPULATION BETWEEN THE WEIGHTS OF 15-36KG WITHOUT ANY INCREASED RISKS. THIS DISPERSIVE ELECTRODE HAS BEEN VALIDATED AS SAFE FOR USE IN THE PATIENT POPULATION FROM 15-35KG. DESPITE BEING UTILIZED OUTSIDE OF THE CURRENT RECOMMENDED WEIGHT RANGE FOR A (B)(6) PATIENT , THIS FACTOR WOULD NOT CONTRIBUTE TO THE INCIDENT AT HAND FOR THIS ELECTRODE HAD BEEN VALIDATED FOR USE IN A PATIENT POPULATION WITH A WEIGHT RANGE OF 15-36KG. THE COMPLAINT CANNOT BE CONFIRMED AND ROOT CAUSES CANNOT BE CONFIRMED WITHOUT EXAMINATION OF THE ACTUAL DEVICE UTILIZED IN THIS REPORTED INCIDENT. THE INABILITY TO ACHIEVE GOOD PAD ADHESION TO THE SKIN IS THE MOST PROBABLE CAUSE FOR THIS COMPLAINT. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED ANY MANUFACTURING DEFECTS WITH THIS COMPLAINT; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. THIS MEDWATCH IS ASSOCIATED WITH MEDWATCH 1720159-2013-00037 THAT WAS REPORTED ON THE ESU (ELECTROSURGICAL UNIT - GENERATOR) THAT WAS INVOLVED IN THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "BLACK MARK NOTICED ON LEG AFTER PROCEDURE WITH 4" BLISTER. THEY CALLED IN A (B)(6) DOCTOR TO LOOK AT LEG AND PATIENT IS OK. PATIENT WAS PEDIATRIC. PACKAGING FROM MACROLYTE WAS NOT RECOVERED, NOT WAS THE SUCTION COAGULATOR/PENCIL. RISK MANAGEMENT HAS PAD. (B)(6) HAS THE PAD FROM THE INCIDENT. ESU IS LEGACY ITEM EXCALIBUR PLUS PC (B)(4). PER REP, BIOMED CHECKED OUT ESU AND IT WAS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46537 MACROLYTE DISPERSIVE ELECTRODE, PEDIATRIC SINGLE DISPERSIVE WITH 10 FOOT CABLE MACROLYTE GROUND PAD GEI CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention