BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ CLEAN NON-STICK ELECTROSURGICAL TIPS

    MDR report key: 2848961 · Received November 15, 2012

    Report

    Report Number
    1721194-2012-00009
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT REPORT WAS DISCOVERED IN A REVIEW OF THE MAUDE DATABASE. (B)(4). MEGADYNE HAS RECEIVED NO SIMILAR REPORTS FROM OUR CUSTOMERS OR FDA AND THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WITHOUT AN EVALUATION OF THE DEVICE OR ADDITIONAL INFO REGARDING THE EVENT WE ARE UNABLE TO CONFIRM THE REPORT. THE MOST LIKELY CAUSES OF THIS TYPE OF INJURY RELATED TO THE ELECTRODE INCLUDE, BUT ARE NOT LIMITED TO, DIRECT CONTACT WITH THE ACTIVATED OR HEATED ELECTRODE TIP, CORONA DISCHARGE, AND CAPACITIVE COUPLING. THESE CAUSES ARE RELATED TO IMPROPER USE. A REVIEW OF THE PRODUCT HISTORY REVEALS THIS TO BE A RELIABLE COMPONENT OF ELECTROSURGERY AND WE ARE UNABLE TO ESTABLISH A CAUSAL RELATIONSHIP BETWEEN THE PROPER INSTALLATION AND USE OF THE DEVICE AND THE REPORTED EVENT. MEGADYNE CONSIDERS THIS TO BE A REPORTABLE EVENT BECAUSE THE DATABASE INDICATES INTERVENTION WAS REQUIRED. NO INFO IS AVAILABLE REGARDING THE TYPE OF EXTENT OF INJURY OR INTERVENTION.

    Description of Event or Problem · 1

    PHYSICIAN WAS USING A VALLEY LAB ROCKER SWITCH PENCIL FOR AN ESU WITH A MEGADYNE NEEDLE TIP. IT WAS NOTED THAT THERE WAS A BURN IN THE INSIDE OF THE PT NARES WHERE THE PHYSICIAN WAS DOING TURBINATE SURGERY. REPORT WAS DISCOVERED DURING A REVIEW OF THE MAUDE DATABASE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ CLEAN NON-STICK ELECTROSURGICAL TIPS FINE NEEDLE ELECTRODE GEI MEGADYNE MEDICAL PRODUCTS, INC. 0118 21573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R VALLEY LAB ROCKER SWITCH PENCIL