BEUDAMED
    FDA Adverse Event Summary report: N

    GOLDLINE MODEL "A" ELECTROSURGICAL PENCIL

    MDR report key: 3037122 · Received April 5, 2013

    Report

    Report Number
    3007305485-2013-00036
    Date Received
    April 5, 2013
    Report Date
    May 7, 2013
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K791137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS JUST BEEN RECEIVED BY CONMED CORPORATION ON (B)(4) 2013. AN INVESTIGATION IS ANTICIPATED; HOWEVER, HAS NOT YET COMMENCED. A SUPPLEMENTAL REPORT WILL BE SENT ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION.

    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 1210173 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. A SMALL SECTION OF THE WIRE OF THE RETURNED DEVICE WAS OBSERVED TO BE FRAYED (CUT) PRIOR TO RECEIVING AT CONMED COMPLAINT HANDLING CENTER. INNER WIRES WERE OBSERVED TO BE EXPOSED OUT OF THE INSULATION. THE COMPLAINT FAILURE MODE WAS CONFIRMED BASED ON THE PRODUCT CONDITION. AN END-USER MIGHT GET SHOCK/BURN DUE TO EXPOSED WIRE. THERE COULD BE MULTIPLE OF POSSIBLE CAUSES FOR THIS FAILURE MODE. IMPROPER ASSEMBLY OF THE DEVICE COULD BE DUE TO MANUFACTURING RELATED DEFECT. IN PROCESS INSPECTION AND VISUAL CHECKS ARE DONE TO ENSURE PROPER PRODUCTION OF THE DEVICES. NO DISCREPANCIES WERE OBSERVED DURING THE REVIEW OF THE MANUFACTURING DOCUMENTS. THE IFU, INSTRUCTIONS FOR USE, SPECIFIES, "THESE DEVICES SHOULD BE INSPECTED BEFORE EACH USE. VISUALLY EXAMINE THE DEVICE FOR OBVIOUS PHYSICAL DAMAGE INCLUDING: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS. BROKEN OR SIGNIFICANTLY BENT CONNECTOR CONTACTS. DAMAGE INCLUDING CUTS, PUNCTURES, NICKS, ABRASIONS, UNUSUAL LUMPS, SIGNIFICANT DISCOLORATION." THUS, ANY DEVICE DAMAGE SHOULD BE DETECTABLE PRIOR TO THE USE. THE IFU ALSO INDICATES, "NEVER ALLOW THE CABLES CONNECTED TO THESE DEVICES TO BE IN CONTACT WITH SKIN OF THE PATIENT OR OPERATOR DURING ELECTROSURGICAL ACTIVATIONS". OTHER POSSIBLE CAUSE COULD BE DUE TO DEVICE DAMAGE AFTER THE PRODUCTION DURING SHIPPING/HANDLING, STORAGE OR USE. NO CONCLUSIVE MANUFACTURING RELATED DEFECTS WERE OBSERVED DURING THE EXAMINATION; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "RESIDENT WAS SHOCKED BY DEVICE - IT CAUSED A SMALL BURN. SHE WENT TO THE ER & WAS TREATED BUT SPECIFIC TREATMENT INFORMATION IS NOT AVAILABLE. EXAMINATION OF THE DEVICE IDENTIFED A FRAY. IT IS NOT KNOWN IF THE FRAY OCCURRED ONCE IN THE SURGICAL FIELD OR IF THE DEVICE WAS RECEIVED THAT WAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141405 GOLDLINE MODEL "A" ELECTROSURGICAL PENCIL CAUTERY PENCIL GEI CONMED ELECTROSURGERY 1210173

    Patients

    Seq Age Sex Outcome Treatment
    1 Other