BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDLINE DISPOSABLE ROCKER SWITCH ELECTROSURGICAL PENCIL

    MDR report key: 3083186 · Received April 29, 2013

    Report

    Report Number
    3007305485-2013-00042
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    May 31, 2013
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K791137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN FDA REPORTABLE EVENT DUE TO A AN INJURY RECEIVED BY END-USER AND TREATMENT, IF ANY, IS UNKNOWN. THE DEVICE IS RECEIVED BY CONMED CORPORATION; HOWEVER, EVALUATION HAS NOT YET BEEN INITIATED. UPON COMPLETION OF THE QUALITY ENGINEERING EVALUATION A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE, THE GOLDLINE DISPOSABLE, ROCKER SWITCH ELECTROSURGICAL PENCIL IS A DEVICE DESIGNED TO BE USED AS AN ACCESSORY IN CONJUNCTION WITH THE ELECTROSURGICAL UNITS AND ELECTRODES WITH WHICH THEY ARE KNOWN TO BE COMPATIBLE. THEIR USE ENABLES THE OPERATOR TO REMOTELY CONDUCT AN ELECTROSURGICAL CURRENT FROM THE OUTPUT CONNECTOR OF AN ELECTROSURGICAL UNIT TO THE OPERATIVE SITE FOR THE DESIRED SURGICAL EFFECT. THESE DEVICES ARE COMPATIBLE WITH CONMED DISPOSABLE STANDARD AND ULTRACLEAN ACTIVE ELECTRODES. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, FOR LOT 1211125 HAS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. ONE (1) USED DEVICE WAS RETURNED TO CONMED COMPLAINT HANDLING CENTER FOR INVESTIGATION. THE RETURNED DEVICE WAS EXAMINED IN THE LABORATORY. THE BLADE ELECTRODE CONNECTED TO THE DEVICE WAS NOT RETURNED TO THE COMPLAINT CENTER FOR INVESTIGATION. THE DEVICE IS SUPPLIED TO THE END-USER WITH A 1" ULTRACLEAN BLADE ELECTRODE. DURING THE INVESTIGATION THE CONNECTION BETWEEN THE ELECTRODE (CONMED BLADE ELECTRODE) AND HANDPIECE (RETURNED DEVICE) WAS FOUND ACCEPTABLE DURING THE REVIEW. THE COMPLAINT DEVICE WAS CONNECTED TO THE SYSTEM 7500 UNIT AND A STEEL PLATE. THE CUT & COAG FUNCTION WORKED WITHOUT ANY DISCREPANCIES. THE COMPLAINT FAILURE MODE WAS NOT REPRODUCED DURING THE EXAMINATION. THE RETURNED DEVICE WAS DISMANTLED DURING THE INVESTIGATION TO CHECK FOR THE WIRE CONNECTION, CUT/COAG BUTTONS CONNECTION. NO VISUAL DAMAGE TO THE WIRE OR THE BUTTONS WAS OBSERVED DURING THE EXAMINATION. NO OBVIOUS PHYSICAL DAMAGE TO THE CORD OR INNER WIRES WAS OBSERVED IN THE RETURNED DEVICE. THE COMPLAINT FAILURE MODE IS NEITHER CONFIRMED NOR UNCONFIRMED AT THIS TIME. POSSIBLE CAUSE OF THE FAILURE MODE COULD BE DUE TO IMPROPER ELECTRODE AND HANDPIECE CONNECTION DURING THE USE. IMPROPER CONNECTION COULD CAUSE SPARKING DURING THE USE IF THE ELECTRODE IS NOT SEATED PROPERLY IN THE HANDPIECE. THE IFU, INSTRUCTIONS FOR USE, MITIGATES THE REPORTED FAILURE MODE BY STATING UNDER SAFETY TIPS TO, "INSPECT AND TEST EACH DEVICE BEFORE USE". UNDER CONTRAINDICATIONS THE IFU STATES THAT, "THESE DEVICES SHOULD NEVER BE USED WHEN: THESE DEVICES FAIL THE INSPECTION DESCRIBED HEREIN". UNDER INSPECTION IN THE IFU IT STATES, "VERIFY THAT THE ELECTRODE IS FULLY AND SECURELY SEATED IN THE HANDPIECE BEFORE USE". A COMPATIBLE ACTIVE ELECTRODE, THE 1" ULTRACLEAN ELECTRODE, IS SUPPLIED WITH THIS HANDPIECE; HOWEVER, USE OF THE DEVICE WITH A NON-COMPATIBLE ACTIVE ELECTRODE COULD CAUSE AN INCOMPLETE CONNECTION WHERE THE ELECTRODE IS SEATED IN THE HANDPIECE AND SPARKING WOULD RESULT. OTHER POSSIBLE CAUSE COULD BE OPERATING THE DEVICE WITH THE ACTIVE BLADE CLOSE TO THE END-USER'S FINGER (I.E. UTILZING YOUR FINGER TO MANIPULATE TISSUE CLOSE TO THE SURGICAL SITE DURING ELECTRODE ACTIVATION). THIS COULD CAUSE SPARKING AND END USER BURN/SHOCK. NO ROOT CAUSE CAN BE CONFIRMED WITHOUT THE REVIEW OF THE ENTIRE DEVICE (ELECTRODE & HANDPIECE). NO CONCLUSIVE MANUFACTURING RELATED DEFECTS WERE OBSERVED WITH THE HANDPIECE UNIT; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "HANDPIECE WAS SPARKING AND CUT THE DOCTOR. TRIED A NEW HANDPIECE AND THE PROBLEM PERSISTED. SWITCHED TO A NEW CAUTERY. USED CONMED 2450, S/N (B)(4) DURING INCIDENTS". IT WAS ALSO REPORTED, "NOT SURE IF DOCTOR RECEIVED TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185439 GOLDLINE DISPOSABLE ROCKER SWITCH ELECTROSURGICAL PENCIL CAUTERY PENCIL GEI CONMED ELECTROSURGERY 1211125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other