BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACROLYTE DISPERSIVE ELECTRODE, PREMIE SINGLE DISPERSIVE WITH 10 FOOT CABLE

    MDR report key: 3770217 · Received April 24, 2014

    Report

    Report Number
    3007305485-2014-00041
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 25, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K120476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED MACROLYTE PREMIE DISPERSIVE ELECTRODES ARE DESIGNED FOR USE WITH ELECTROSURGICAL GENERATORS DURING ELECTROSURGERY AND PROVIDE A PATH FOR RF ENERGY PRODUCED AT THE ACTIVE ELECTRODE TO RETURN TO THE GENERATOR. THIS DISPERSIVE ELECTRODE IS INTENDED FOR USE ON LOW-BIRTH WEIGHT INFANTS, WEIGHING LESS THAN (B)(6) AND SHOULD ONLY BE USED BY, OR UNDER THE SUPERVISION OF, A TRAINED PHYSICIAN, IN HOSPITAL AND SURGICAL CENTERS WHERE PROCEDURES USING RF ENERGIES ARE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR/LHR FOR LOT 1305315 HAS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. IN PROCESS INSPECTION & VISUAL CHECKS WERE PERFORMED TO ENSURE PROPER PRODUCTION OF THE SHIPPED DEVICES. NO OBVIOUS DISCREPANCIES WERE OBSERVED WITH THE DHR/LHR DOCUMENTS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. ONE (1) 440-2400 MACROLYTE WAS REPORTED AS A CUSTOMER COMPLAINT STATING: "DURING SURGICAL PROCEDURE THE SURGICAL OPERATING TEAM NOTICED A BURNING SMELL WHEN USING DIATHERMY ON THE PATIENT. OPERATING CEASED AND ALL EQUIPMENT AND PATIENT CHECKED FOR SIGNS OF BURNING. IT WAS NOTICED THE SMELL WAS FROM THE DIATHERMY PLATE WHICH WAS SITUATED ON THE PATIENT'S RIGHT THIGH. DIATHERMY PLATE REMOVED AND SIGN AND PATIENT CHECKED FOR BURN. NO PATIENT BURN. THE DIATHERMY PLATE HAD STARTED TO BURN AT WIRES NEAR PATIENT. NO INJURY TO PATIENT". NO PRODUCT WAS RETURNED FOR EXAMINATION OR CONFIRMATION OF DEFECT OR CONFIRMATION OF A CONMED PRODUCT. A PHOTOGRAPH OF THE PRODUCT WAS RECEIVED FROM THE END-USER FACILITY. NO ROOT CAUSES CAN BE CONFIRMED WITHOUT EXAMINATION OF THE PRODUCT; HOWEVER, A PICTURE OF THE COMPLAINT PRODUCT WAS RECEIVED FROM THE END-USER FACILITY. A BLACKENED TAB AREA DUE TO CHARRING WAS OBSERVED DURING THE REVIEW. THUS, THE COMPLAINT FAILURE MODE WAS CONFIRMED BASED ON THE PICTURE OF THE DEVICE. ALSO, THE COMPLAINT FAILURE MODE WAS REPRODUCED THROUGH A STUDY PROTOCOL PERFORMED DURING THE FAILURE MODE INVESTIGATION. SIMILAR COMPLAINTS WERE RECEIVED FOR THE REPORTED FAILURE MODE (SEE REFERENCED MEDWATCH REPORTS BELOW). PRODUCT CONTAINMENT ACTION WAS PERFORMED THROUGH A SHIP-HOLD AND RISK TO PATIENT WAS ADDRESSED THROUGH A HEALTH HAZARD EVALUATION. A CAPA WAS INITIATED TO ADDRESS THE ROOT CAUSE AND CORRECTIVE ACTION PLAN. NO FURTHER CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. THE FOLLOWING MEDWATCH REPORTS ARE ALL ASSOCIATED: 3007305485-2014-00041, 3007305485-2014-00042, 3007305485-2014-00043, 3007305485-2014-00044, 3007305485-2014-00045, AND, 3007305485-2014-00046. NEVER RETURNED TO CONMED CORP.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING HELD BY THE END-USER FACILITY; THEREFORE, A DIRECT EVALUATION OF THE ACTUAL DEVICE WILL NOT BE CONDUCTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ON COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION. DEVICE BEING HELD BY END-USER.

    Description of Event or Problem · 1

    IT WAS REPORTED, "DURING SURGICAL PROCEDURE, THE SURGICAL OPERATING TEAM NOTICED A BURNING SMELL WHEN USING DIATHERMY ON THE PATIENT. OPERATING CEASED AND ALL EQUIPMENT AND PATIENT CHECKED FOR SIGNS OF BURNING. IT WAS NOTICED THE SMELL WAS FROM THE DIATHERMY PLATE WHICH WAS SITUATED ON THE PATIENTS RIGHT THIGH. DIATHERMY PLATE REMOVED AND SIGN AND PATIENT CHECKED FOR BURN. NO PATIENT BURN. THE DIATHERMY PLATE HAD STARTED TO BURN AT WIRES NEAR PATIENT. NO INJURY TO PATIENT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249205 MACROLYTE DISPERSIVE ELECTRODE, PREMIE SINGLE DISPERSIVE WITH 10 FOOT CABLE MACROLYTE GROUND PAD GEI CONMED CORPORATION 1305315

    Patients

    Seq Age Sex Outcome Treatment
    1