BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE RETURN ELECTRODE

    MDR report key: 1982623 · Received January 13, 2011

    Report

    Report Number
    1717344-2011-00025
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    November 17, 2010
    Report Date
    December 14, 2010
    Manufacturer
    COVIDIEN LP (VALLYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT: (B)(4) 2011. THE CUSTOMER REPORTED, THE INCIDENT DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. THE PRODUCT INSTRUCTIONS FOR USE WARN 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 RF CURRENT) INCREASE THE RISK OF EXCESSIVE HEATING UNDER A FULLY APPLIED RETURN ELECTRODE TO THE POINT OF INJURING THE PT. USE OF MORE THAN ONE PT RETURN ELECTRODE MAY HELP MITIGATE THE INCREASED RISK. THIS INFO FROM THE IFU WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UPON REMOVAL OF THE GROUNDING PADS FOLLOWING A LIVER ABLATION PROCEDURE (WHERE A NON-COVIDIEN GENERATOR HAD BEEN USED), IT WAS NOTED THAT THE PT WAS BURNED AT THE PAD SITES. THE BURNS WERE DESCRIBED AS 1ST AND 2ND DEGREE. FOUR PADS HAD BEEN PLACED ON THE PT; ONE ON EACH SIDE OF BOTH OF THE PATIENT'S LEGS. THE PROCEDURE TOOK 2 HOURS. PRIMARY TREATMENT BY X-RAY STAFF WAS COOL PACKS ON THE BURN AREAS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYHESIVE RETURN ELECTRODE PATIENT RETURN ELECTRODE GEI COVIDIEN LP (VALLYLAB) 154945

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR