BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESUREFIT DISPERSIVE ELECTRODE

    MDR report key: 2810202 · Received October 18, 2012

    Report

    Report Number
    3007305485-2012-00102
    Event Type
    Other
    Date Received
    October 18, 2012
    Date of Event
    September 24, 2012
    Report Date
    December 28, 2012
    Manufacturer
    CONMED CORP
    Product Code
    GEI
    PMA / PMN Number
    K120322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUREFIT DISPERSIVE ELECTRODES ARE INDICATED FOR USE WITH ONLY THOSE ELECTROSURGICAL GENERATORS EQUIPPED WITH CONTACT QUALITY MONITORING SYSTEMS (I.E. REM, ARM, NESSY, ETC.) DURING ELECTROSURGERY AND PROVIDE A PATH FOR RF ENERGY PRODUCED AT THE ACTIVE ELECTRODE TO RETURN TO THE GENERATOR. THE SUREFIT 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. THE ELECTROSURGICAL GENERATOR UTILIZED BY THE END-USER DURING THIS REPORTED INCIDENT WAS A CONMED SYSTEM 5000 ESU EQUIPPED WITH A CONTACT QUALITY MONITORING SYSTEM OF ARM, AUTOMATIC RETURN MONITOR. NO PRODUCT WAS RETURNED BY THE END-USER TO CONMED CORPORATION; THEREFORE, NO LABORATORY EXAMINATION WAS PERFORMED ON THE COMPLAINT PRODUCT. ALSO THERE WERE NO PICTURES AVAILABLE OF THE DEVICE OR OF THE REPORTED "BURN"; THEREFORE, CONMED CANNOT MAKE A CONFIRMATION OF ANY PRODUCT DEFECT, OR, CONFIRM THAT A CONMED PRODUCT WAS UTILIZED IN THE REPORTED INCIDENT. THERE MAY BE A MULTIPLE OF POSSIBLE CAUSES EITHER MANUFACTURING OR USER RELATED; HOWEVER, THE COMPLAINT CAN BE NEITHER CONFIRMED NOR UNCONFIRMED AT THIS TIME. POSSIBLE CAUSE FOR THIS FAILURE MODE COULD BE IMPROPER PAD SITE PREPARATION RESULTING IN POOR ELECTRODE ADHESION TO THE PATIENT. THE IFU, INSTRUCTIONS FOR USE, SPECIFIES, "PREPARE THE SKIN AT THE APPLICATION SITE ACCORDING TO FACILITY PROTOCOL. IF NO PROTOCOL EXISTS, CLIP EXCESSIVE HAIR AT APPLICATION SITE, CLEAN AND DISINFECT AREA TO REMOVE OILS, LOTIONS, ETC., AND ALLOW TO DRY THOROUGHLY". THE IFU ALSO INSTRUCTS TO, "APPLY ELECTRODE FIRMLY, ENSURING FULL ADHESION AND CONTACT WITH PATIENT'S SKIN". THE IFU WARNS THAT, "FAILURE TO ACHIEVE GOOD SKIN CONTACT BY THE ENTIRE ADHESIVE SURFACE MAY RESULT IN AN ELECTROSURGICAL BURN OR POOR ELECTROSURGICAL PERFORMANCE". UNABLE TO ACHIEVE GOOD ELECTRODE ADHESION TO THE PATIENT'S SKIN COULD BE A PROBABLE CAUSE FOR THIS COMPLAINT. NO ROOT CAUSES CAN BE CONFIRMED WITHOUT EXAMINATION OF THE ACTUAL PRODUCT. THE QUALITY ENGINEERING COMPLAINT INVESTIGATION HAS NOT IDENTIFIED ANY MANUFACTURING DEFECTS WITH THIS DEVICE; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE UTILIZED IN THE INCIDENT HAS BEEN DISCARDED BY THE END-USER FACILITY. UPON COMPLETION OF THE QUALITY ENGINEERING EVALUATION OF THE REPORTED INCIDENT A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(6) HOSPITAL REPORTED THIS EVENT ON (B)(6) 2012 TO CONMED CORPORATION AS FOLLOWS, "PAD SITE BURN WAS DISCOVERED POST-OPERATIVELY. THE EDGE FOIL WAS CHARRED ON THE PAD AND THE PT WAS INJURED." ORIGINALLY THIS WAS REPORTED AS A DEVICE WITH AN UNK LOT NUMBER. FURTHER INFORMATION RECEIVED FROM THE END-USER FACILITY, ON (B)(6) 2012, THAT THE PT WAS MEDICALLY TREATED FOR A SKIN BURN; HOWEVER, DETAILS OF THE TREATMENT ARE NOT KNOWN. THE MEDWATCH REPORT #(B)(4), RECEIVED BY CONMED ON (B)(4) 2012, REPORTED THE EVENT DESCRIPTION AS FOLLOWS, "BOVIE MACHINE STARTED TO ALARM AND SHUT DOWN RIGHT AFTER THE PROCEDURE STARTED. THE BOVIE PAD CHECKED AND WAS PLANNED TO BE PEELING AWAY FORM THE SKIN. THE BOVIE PAD HAD A BURNT AREA AND THE PT'S THIGH HAD A BURN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESUREFIT DISPERSIVE ELECTRODE SUREFIT GROUND PAD GEI CONMED CORP NA 1204275

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ELECTRO-SURGICLA UNIT| SYSTEM 5000 ESU