BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI PWR DISPOSBL GRNDING PAD

    MDR report key: 1033032 · Received April 22, 2008

    Report

    Report Number
    1717344-2008-00165
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 31, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    ODR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 04/22/2008. DGPHP SITE BURNS CAN BE THE RESULT OF A NUMBER OF CAUSES INCLUDING PLACEMENT, DURATION OF TREATMENT AND POWER SETTINGS, PT CONDITION, AND POTENTIALLY BY FAILURE OF THE DISPERSIVE ELECTRODE TO PERFORM AS INTENDED. IN THIS CASE, WITHOUT THE RETURN OF THE INCIDENT DISPERSIVE ELECTRODE, WE WERE UNABLE TO DETERMINE IF ANY DEFECT OF THE PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENT. ONE OF THE CAUSES OF BURNS IN POOR DGPHP PLACEMENT. AS NOTED ABOVE, PROPER PLACEMENT OF THE DGPHP AND ENSURING GOOD CONTACT THROUGHOUT THE PROCEDURE (ESPECIALLY IF THE PT IS REPOSITIONED) ARE CRITICAL COMPONENTS TO AVOIDING BURNS. THIS IS COVERED IN DETAIL IN OUR IFU. FUTHERMORE, WE ARE AWARE THAT SOME CUSTOMERS REUSE PADS EVEN THOUGH THEY ARE CLEARLY LABELED AS SINGLE USE DEVICES. REUSED DISPERSIVE ELECTRODES CAN DRY OUT AND BE A SOURCE FOR BURNS BECAUSE THEY DO NOT CONDUCT ELECTRICAL CURRENT PROPERLY. WE ARE CLOSELY MONITORING THE INCIDENCE RATE OF DISPERSIVE ELECTRODE BURNS. THE RATE OF BURNS FOR VALLEYLAB DGPHP DISPERSIVE ELECTRODES CONTINUES TO BE LOWER THAN THE OVERALL RATE OF RADIO FREQUENCY ABLATION DISPERSIVE ELECTRODE BURNS AS SITED IN CURRENT MEDICAL LITERATURE. CONTINUOUS IMPROVEMENT EFFORTS ARE ON-GOING TO ENSURE THAT CUSTOMERS ARE PROPERLY TRAINED AND OUR IFU CLEARLY ILLUSTRATES THE PROPER PLACEMENT OF THE DISPERSIVE ELECTRODES. WE ALSO REINFORCE THE IMPORTANCE OF NOT REUSING THESE SINGLE USE DEVICES TO THE CUSTOMER WHENEVER THE OPPORTUNITY ARISES.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A RADIO FREQUENCY ABLATION PROCEDURE, THE CABLE OF THE RIGHT PAD BECAME HOT. IT SOON BECAME COOLER, SO THE PROCEDURE WAS CONTINUED. HOWEVER, THE LEFT THIGH WAS GETTING HOTTER AND THE PT COMPLAINED OF PAIN SO ABLATION WAS STOPPED. UPON REMOVING THE PT RETURNED ELECTRODES (PADS), THEY FOUND 2ND DEGREE BURN ON BOTH THIGHS AND THE PADS HAD BECOME DARKENED. THE GENERATOR STARTED AT 50W AND REACHED A MAXIMUM OF 120W WITH A SINGLE ABLATION OF 7 MINS. THE PAIR OF PADS WERE NEW. THE BURN WAS TREATED WITH OINTMENT. THERE WAS NO CHANGE IN THE PT'S POSITION DURING THE PROCEDURE AND THERE ARE NO PICTURES OF THE BURN AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI PWR DISPOSBL GRNDING PAD ELECTROSURGICAL ACCESSORY ODR COVIDIEN LP (VALLEYLAB) IN3156

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR CT-2030 - NEEDLE ELECTRODE - LOT # UNK