BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 4192955 · Received October 22, 2014

    Report

    Report Number
    1717344-2014-00909
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 25, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE E7506 INSTRUCTIONS FOR USE (IFU) CONTAINS A WARNING THAT THEIR USE IN NON-TRADITIONAL PROCEDURES THAT UTILIZE HIGH CURRENT, LONG DUTY CYCLES, OR BOTH (FOR EXAMPLE: TISSUE LESIONING, TISSUE ABLATION, TISSUE VAPORIZATION, AND PROCEDURES IN WHICH CONDUCTIVE FLUIDS SUCH AS SALINE OR LACTATED RINGER'S SOLUTION ARE INTRODUCED INTO THE SURGICAL SITE FOR DISTENTION OR TO CONDUCT THE RF CURRENT) INCREASE THE RISK OF EXCESSIVE HEATING UNDER A FULLY APPLIED RETURN ELECTRODE TO THE POINT OF INJURING THE PATIENT. USE OF MORE THAN ONE RETURN ELECTRODE MAY HELP MITIGATE THE INCREASED RISK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT HAD UNDERGONE A RENAL RF ABLATION PROCEDURE WITHOUT ANY COMPLICATIONS. UPON REMOVAL OF THE GROUNDING PAD, AN AREA OF REDNESS WAS NOTED ON THE PATIENT'S THIGH. THE FOLLOWING DAY IT WAS NOTED THAT THE RED AREA WAS BLISTERED. FOUR GROUNDING PADS WERE IN USE FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674156 POLYHESIVE RETURN ELECTRODE PATIENT GROUNDING PAD GEI COVIDIEN LP E7506

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC RF3000 ABLATION GENERATOR