BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP. IMA/ENT 3/4 NEEDLE ELECTRODE

    MDR report key: 6701448 · Received July 11, 2017

    Report

    Report Number
    3011137372-2017-00234
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 27, 2017
    Report Date
    June 27, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HGI
    PMA / PMN Number
    K942986
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). DHR WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO 809337. 1) SAMPLE OF 809337 WAS RECEIVED FOR EVALUATION. LOT # UNKNOWN. THE DEVICE IS BLACKENED AROUND THE TIP AND ORGANIC MATERIAL IS ENCRUSTED ALONG THE INSULATED SHAFT. THE SURFACE WAS GENTLY SCRAPED TO REMOVE THE ENCRUSTED ORGANIC MATERIAL UNDER MAGNIFICATION TO EXPOSE THE BASE INSTRUMENT. SEVERAL FIBERS WERE SUSPENDED IN THE ORGANIC MATERIAL WHICH APPEARED TO BE A MIXTURE OF HAIR AND COTTON FIBERS. AFTER CLEANING THE BASE INSTRUMENT WAS INSPECTED. THE INSULATION WHICH SURROUNDS THE WORKING SHAFT WAS INTACT A SMALL AREA NEAR THE TIP SHOWED SIGNS OF CHARRING FROM THE FIRE EVENT. THE DEVICE WAS INSPECTED UNDER HIGH MAGNIFICATION FOR SIGNS OF ELECTRICAL ARCING. NO EVIDENCE OF ARCING DAMAGE THROUGH THE DIELECTRIC COULD BE FOUND. THE NEEDLE POINT SHOWS SIGNS OF ELECTRICAL ARCING AT THE POINT OF THE SHARPENED TIP WHICH IS THE INTENDED POINT OF PATIENT CONTACT. ELECTRICAL ARCING SHOULD NEVER OCCUR DURING USE. THIS ONLY HAPPENS WHEN THE ELECTRODE IS NOT IN CONTACT WITH THE PATIENT WHEN THE ENERGY IS ENGAGED. ELECTRICAL POWER WAS OTHER REMARKS: CONDUCTED TO THE "POINT OF USE" AS WAS DESIGNED. THERE ARE NO MOVING OR FUNCTIONING "PARTS" IN THIS DEVICE. THERE IS NO MEASUREABLE DAMAGE TO THE DEVICE. IT WAS PRESENT IN THE "FIRE" BUT DID NOT CONTRIBUTE ANY OXIDIZED MATERIAL TO THE FIRE EVENT. POTENTIAL ROOT CAUSES OF THE FIRE ARE ONE OR MORE USER ERROR(S) INCLUDING- PRESENCE OF COMBUSTIBLE MATERIAL AT USAGE POINT. INADEQUATE CONTACT WITH PATIENT OR POWER SETTINGS TOO HIGH ACCIDENTAL DIRECT CONTACT WITH GROUND PLANE. AFTER EXTENSIVE EXAMINATION OF THE ELECTRODE IT WAS DETERMINED THAT THE ELECTRODE MAY HAVE INITIATED THE FIRE - BUT THIS WAS NOT THE RESULT OF A DEVICE FAILURE. (B)(4).

    Description of Event or Problem · 1

    THE ITEM CAUGHT ON FIRE WHILE IN USE. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THE ITEM CAUGHT ON FIRE WHILE IN USE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484701 DISP. IMA/ENT 3/4 NEEDLE ELECTRODE ELECTROCAUTERY,GYNECOLOGIC,ACCESSO HGI TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1