BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDLINE DISPOSABLE PUSH BUTTON ELECTROSURGICAL PENCIL

    MDR report key: 3056223 · Received April 12, 2013

    Report

    Report Number
    3007305485-2013-00040
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    May 24, 2013
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K791137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS DESIGNED TO BE USED AS ACCESSORIES 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 FOR LOT 1203295 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 CENTER FOR INVESTIGATION. THE RETURNED DEVICE WAS EXAMINED IN THE LABORATORY. THE COMPLAINT PRODUCT WAS CONNECTED TO AN ESU, ELECTROSURGICAL UNIT, & A STEEL GROUNDING PLATE. THE CUT & COAG FUNCTION OF THE COMPLAINT DEVICE WAS CHECKED AT POWER SETTINGS OF 70, 75 ,80 & 85 W. NO CUT OR COAG DISCREPANCIES WERE OBSERVED DURING THE EXAMINATION. AUTO/SELF ACTIVATION OF THE CUT OR COAG FUNCTION WAS NOT OBSERVED DURING THE TESTING. THERE COULD BE MULTIPLE OF POSSIBLE CAUSES FOR THIS FAILURE MODE. IMPROPERLY ASSEMBLED DEVICE COULD BE POSSIBLE CAUSE FOR THIS FAILURE MODE. THE IFU, INSTRUCTIONS FOR USE, SPECIFIES, "INSPECT AND TEST EACH DEVICE BEFORE USE". THUS, ANY DEVICE DISCREPANCIES SHOULD BE DETECTABLE PRIOR TO USE. THE IFU ALSO SPECIFIES, "USE LOWEST POSSIBLE POWER SETTING ON THE ASSOCIATED ELECTROSURGICAL UNIT CAPABLE OF ACHIEVING DESIRED SURGICAL EFFECT. ACTIVATION TIME SHOULD BE AS SHORT AS POSSIBLE". THE CUT & COAG FUNCTION WORKED AS INTENDED DURING THE PRODUCT TESTING. THE COMPLAINT FAILURE MODE WAS NOT REPRODUCED DURING THE EXAMINATION. NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THIS IS AN FDA REPORTABLE EVENT DUE TO A SENTINEL EVENT REPORTED ON MEDWATCH 1720159-2011-00057. THE DEVICE IS EXPECTED; HOWEVER, HAS NOT YET BEEN RECEIVED BY CONMED CORPORATION. UPON COMPLETION OF THE QUALITY ENGINEERING EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "COAG OUTPUT WITHOUT PRESSING THE BUTTON." (ELECTROSURGICAL PENCIL SELF-ACTIVATION). IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158108 GOLDLINE DISPOSABLE PUSH BUTTON ELECTROSURGICAL PENCIL CAUTERY PENCIL GEI CONMED ELECTROSURGERY 1203295

    Patients

    Seq Age Sex Outcome Treatment
    1