BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 3252616 · Received July 15, 2013

    Report

    Report Number
    1717344-2013-00514
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    May 23, 2013
    Report Date
    July 10, 2013
    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 INCIDENT GROUNDING PAD WAS DISCARDED BY THE USER AND IS NOT AVAILABLE FOR EVALUATION. THE E7506 INSTRUCTIONS FOR USE WARNS THAT 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 UNDERWENT A TUMOR ABLATION IN THE LEFT KIDNEY ON (B)(6) 2013. HIGH SWEATING WAS OBSERVED WHEN THE GROUNDING PADS WERE REMOVED, WITH ERYTHEMA NOTED AT ONE GROUNDING PAD SITE. NO FURTHER COMPLICATIONS WERE EXPERIENCED SO NO IMPORTANCE WAS GIVEN TO THE ERYTHEMA. APPROXIMATELY ONE MONTH AFTER THE PROCEDURE DURING A FOLLOW-UP VISIT, THE PHYSICIAN NOTICED AN INJURY AT THE SITE WHERE THE ERYTHEMA WAS NOTICED. THE PHYSICIAN BELIEVES THAT DUE TO EXCESSIVE SWEATING THE PAD COULD HAVE PARTIALLY BECOME DETACHED DURING THE PROCEDURE AND THE DISPERSION SURFACE WAS DECREASED, RESULTING IN A BURN. TYPE OF TREATMENT, IF ANY, IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THE INCIDENT SAMPLE WAS DISCARDED BY THE SITE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327703 POLYHESIVE RETURN ELECTRODE PATIENT GROUNDING PAD GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR ABLATION NEEDLE: #M001262160, L/N (B)(4)| RF3000 ABLATION GENERATOR: SN UNK