BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDTROL GOLDLINE PENCIL

    MDR report key: 3864233 · Received June 10, 2014

    Report

    Report Number
    3007305485-2014-00068
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 16, 2014
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K791137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO CONMED CORPORATION FOR EVALUATION. WITHOUT THE INVOLVED DEVICE, AN EVALUATION THEREFORE COULD NOT BE PERFORMED AND THE ROOT CAUSE OF THIS REPORTED INCIDENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE NO ISSUES OR ANY ABNORMALITIES NOTED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. A TWO YEAR COMPLAINT HISTORY REVIEW OF THE HAND-TROL PENCIL FAMILY OF DEVICES SHOWS, OTHER THAN THIS REPORTED INCIDENT, THERE HAVE BEEN NO ADVERSE EVENTS RECEIVED FOR THE ENTIRE PRODUCT FAMILY. THE HANDTROL PENCIL IS A SINGLE USE, STERILE ELECTROSURGICAL HANDPIECE DESIGNED TO BE USED AS AN ACCESSORY IN CONJUNCTION WITH THOSE ELECTROSURGICAL UNITS AND ELECTRODES WITH WHICH THEY ARE KNOWN TO BE COMPATIBLE. THESE ELECTROSURGICAL PENCILS ARE USED FOR THE CONTROLLED DESTRUCTION OF HUMAN TISSUE (COAGULATION AND CUTTING) IN SURGICAL PROCEDURES TO PROVIDE A THERAPEUTIC BENEFIT. THE RISK OF IGNITING FLAMMABLE GASES OR OTHER MATERIALS IS INHERENT IN ELECTROSURGERY AND CANNOT BE ELIMINATED BY DEVICE DESIGN. SOME MATERIALS, FOR EXAMPLE, COTTON, WOOL, AND GAUZE, MAY BE IGNITED BY SPARKS PRODUCED IN NORMAL USE OF AN ELECTROSURGICAL UNIT AND ELECTROSURGICAL PENCIL. THE AORN (ASSOCIATION OF PERIOPERATIVE REGISTERED NURSES) PERIOPERATIVE STANDARDS AND RECOMMENDED PRACTICES, RECOMMENDED PRACTICES FOR ELECTROSURGERY, RECOMMENDATION II, PARAGRAPH 8 READS: "SPONGES USED CLOSE TO THE ACTIVE ELECTRODE TIP SHOULD BE MOIST TO PREVENT UNINTENTIONAL IGNITION. ACTIVE ELECTRODES SHOULD NOT BE CLEANED WITH A DRY SPONGE. FIRES HAVE RESULTED FROM IGNITION OF DRY SPONGES NEAR THE INCISION SITE". IN THE PERIOPERATIVE FIELD THIS IS A KNOWN ISSUE REGARDING ELECTROSURGICAL PROCEDURES AND PRECAUTIONS SHOULD BE TAKEN BY THE END-USER TO PREVENT FIRES. CORRECTED DATA: THE DATE OF THIS REPORT WAS REPORTED INCORRECTLY ON THE INITIAL SUBMISSION OF THIS MEDWATCH AND THE CORRECTED DATE OF 05/16/2014. DEVICE NEVER RETURNED TO CONMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS REPORTED AS NOT AVAILABLE BY THE END-USER; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE IS NOT POSSIBLE. I AM ATTEMPTING TO OBTAIN FURTHER INFORMATION SURROUNDING THIS EVENT. UPON COMPLETION OF THE QUALITY ENGINEERING EVALUATION A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE DISCARDED BY END-USER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE END-USER INDICATED THAT THE REPORTED INCIDENT OCCURRED AT THE BEGINNING OF THE SURGICAL PROCEDURE. THE PHYSICIAN PERFORMED THE INITIAL CUTANEOUS INCISION WITH A SCALPEL. THE SURGEON THEN ATTEMPTED TO INCISE THE SUBCUTANEOUS TISSUE UTILIZING THE HANDTROL PENCIL. ON ACTIVATION OF THE PENCIL THE SURGEON NOTICED AN "ARC" FROM THE ACTIVE ELECTRODE TO THE TISSUE. THE CAUTERY SETUP (ESU SETTINGS, WIRES, DISPERSIVE ELECTRODE) WERE ALL CHECKED AND THE OPERATING STAFF DEEMED ALL WERE SET UP PROPERLY AND OKAY TO CONTINUE. THE PHYSICIAN THEN PROCEEDED AGAIN WITH THE HANDTROL PENCIL AND AGAIN IT "ARCED" CATCHING A 4X4 POSITIONED NEXT TO THE INCISION ON FIRE AND IN TURN THE 4X4 STARTED FIRE ON THE BLUE DRAPE. THE FIRE WAS DOUSED WITH SALINE SOLUTION. THE PENCIL WAS CHANGED AND PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. AS PREVIOUSLY REPORTED ON THE INITIAL MDR, THE SMALL BURN WAS TREATED WITH BACITRACIN OINTMENT AND A STERILE DRESSING. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE DAY OF THE SURGICAL PROCEDURE. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PATIENT FOR INSERTION OF PORT. DURING USE OF CAUTERY, WHICH WAS SET AT 40, A FLAME IGNITED ON THE STERILE BLUE TOWEL DRAPING THE PATIENT. FLAME WAS SMOTHERED AND PATIENT WAS IMMEDIATELY DOUSED WITH 0.9% NS BY SURGEON. THE CAUTERY PENCIL AND TIP FOR THE PENCIL WERE CHANGED IMMEDIATELY. PATIENT SUFFERED A BURN 1 CM BY 1 CM ON RIGHT SIDE OF CHEST, SECOND DEGREE BURN. PATIENT REMAINED STABLE DURING EVENT." IT WAS ALSO REPORTED THAT THE TREATMENT FOR THE BURN WAS BACITRACIN OINTMENT AND A STERILE DRESSING. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE DAY OF THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338153 HANDTROL GOLDLINE PENCIL HANDTROL PENCIL GEI CONMED ELECTROSURGERY 1401243

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention