BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI PWR DISPOSBL GRNDING PAD

    MDR report key: 1052312 · Received May 23, 2008

    Report

    Report Number
    1717344-2008-00224
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 16, 2008
    Manufacturer
    COVIDIEN LP, (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE REPORTED, THESE WERE OLD PADS, BUT DID NOT REPORT LOT #. DGPHP SITE BURNS CAN BE THE RESULT OF A NUMBER OF CAUSES INCLUDING PLACEMENT, DURATION OF TREATMENT AND POWER SETTINGS, PATIENT 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 IS 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. FURTHERMORE, 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 CITED 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 A RADIO FREQUENCY ABLATION PROCEDURE WAS PERFORMED WITH THE OUTPUT AT 40W FOR FIVE 12-MIN ABLATIONS. TWO HOURS LATER, 3 MORE 12-MIN ABLATIONS WERE DONE. WHEN REMOVING THE PT RETURN ELECTRODES AT THE END OF THE PROCEDURE, A 7X5CM BURN AND A 5X3.5CM BURN WHERE FOUND ON PT'S RIGHT THIGH. THESE WERE REPORTED AS 3RD DEGREE BURNS. THE PT WAS TREATED WITH GEBEN CREAM. THERE WAS NO POSITION CHANGE DURING THE PROCEDURE. THE PT'S LENGTH OF HOSPITAL STAY WAS EXTENDED DUE TO BURN INJURY. THE SITE USED OLD PADS THE CUSTOMER HAD KEPT, NOT THE ONES INCLUDED WITH THE NEEDLE. THE NURSE WHO PUT THE PADS ON THE PT STATES THERE WAS ENOUGH GEL ON THE RIGHT PAD. WHILE THEY FELT THE LEFT PAD HAD LESS GEL, NO BURN WAS FOUND ON THE LEFT THIGH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O