BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLIEF COOLED RADIOFREQUENCY KIT

    MDR report key: 8488412 · Received April 5, 2019

    Report

    Report Number
    8030647-2019-00038
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 14, 2019
    Report Date
    May 8, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    GXI
    PMA / PMN Number
    K053082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ON SAMPLE DEVICE WAS RETURNED. A VERY "TINY" MATERIAL PIECE WAS RECEIVED. NO PROBE WAS RECEIVED. THE RETURNED HARD MATERIAL WAS INSPECTED, EXAMINED AND EVALUATED. THE MATERIAL LOOKED LIKE WHITE HARD PLASTIC. THIS MATERIAL DID NOT LOOK LIKE STEEL OR WIRE. THE HARD MATERIAL APPEARED TO BE DIRTY WITH BLACK PARTICLES ALL OVER. A ROOT CAUSE COULD NOT BE IDENTIFIED. THE ORIGIN OF THE BROKEN PIECE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 09-MAY-2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 05-APR-2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A SHARP AND WHITE LIKE HEAVY GAUGE FISHING LINE PIECE OF METAL HAD MIGRATED OUT OF THE PATIENT'S SKIN. THE PATIENT'S FAMILY MEMBER HAD TO USE TWEEZERS AND PULL HARD TO REMOVE THE METAL PIECE. THE FAMILY REPORTED IT FELT AS IF THE METAL PIECE WAS STUCK ON A LITTLE BLOOD CLOT UNDER SKIN. IT BROKE OFF DURING REMOVAL BUT THE FAMILY MEMBER BELIEVES HE REMOVED ALL OF IT. AFTER REMOVING THE METAL PIECE, THAT AREA OF THE PATIENT'S SKIN HEALED QUICKLY. IT TOOK TWO WEEKS FOR THE METAL PIECE TO SURFACE, THAT FAR, OUT OF THE SKIN. THE NURSE REPORTED THE PATIENT HAD A RIGHT KNEE RADIOFREQUENCY ABLATION (RFA) ON (B)(6) 2019. THE PATIENT UNDERWENT KNEE ARTHROSCOPY AND KNEE SURGERY PRIOR TO THE RFA. THE PATIENT REPORTED THAT AFTER THE RFA, SHE NOTICED A BUMP AND EVENTUALLY THE PIECE OF METAL WORKED ITS WAY OUT OF THE SKIN AND WAS REMOVED. THERE WERE NO SIGNS AND SYMPTOMS OF INFECTION. THE PATIENT IS NOW PAIN FREE SINCE THE RFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282095 COOLIEF COOLED RADIOFREQUENCY KIT COOLED RF PROBES AND CANNULAS GXI AVANOS MEDICAL INC. CRK-17-75-4 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR