BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COLLED RF PROBE

    MDR report key: 11038364 · Received December 18, 2020

    Report

    Report Number
    8030647-2020-00118
    Event Type
    Injury
    Date Received
    December 18, 2020
    Report Date
    December 18, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    GXI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CODE(S)-NO CODE AVAILABLE: FOREIGN BODY AND BLEEDING. NOTE: SEARCH OF THE MAUDE DATABASE DID NOT REVEAL ANY NEW REPORTS PREVIOUSLY UNKNOWN TO AVANOS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 17-DEC-2020 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 COMP-GHC-20-03333.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A POSTER AT THE VIRTUAL ASRA CONFERENCE ENTITLED "COMPARING ADVERSE EVENTS ASSOCIATED WITH TRADITIONAL AND COOLED RADIOFREQUENCY ABLATION: A RETROSPECTIVE DATABASE REVIEW" THAT SEVERAL INJURIES OCCURRED FROM USE OF THE DEVICE. THE DATA USED FOR THE PRESENTATION WAS REPORTEDLY OBTAINED FROM THE MAUDE DATABASE NOTING THE YEARS 2010 THROUGH 2020. THE CRITERIA USED IN THE MAUDE SEARCH, AS WELL AS INDIVIDUAL MAUDE REFERENCE NUMBERS WERE NOT PROVIDED. IT IS NOT POSSIBLE TO DETERMINE HOW MANY DEVICES OR PATIENTS WERE INVOLVED. NO SPECIFIC DETAILS FOR THE REFERENCED EVENTS WAS PROVIDED FROM THE POSTER AT THE VIRTUAL ASRA CONFERENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505275 UNKNOWN COLLED RF PROBE PAIN MANAGEMENT GENERATORS & ACCESSORIES GXI AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other