BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED SHARP RF CANNULA, RADIOPAQUE MARKER

    MDR report key: 16283860 · Received February 2, 2023

    Report

    Report Number
    8030647-2023-00021
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    January 5, 2023
    Report Date
    September 1, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    GXI
    UDI-DI
    00193493986446
    PMA / PMN Number
    K972846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30229006, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 31-AUG-2023 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 21 CFR 803, 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 · 0

    CORRECTION: D1, D2, D4 AND G4 ALL INFORMATION REASONABLY KNOWN AS OF 18-MAY-2023 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 · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 01-FEB-2023 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE "MARKER APPEARED TO COME OFF AS CANNULA WAS ADVANCED IN POSTERIOR SOFT TISSUES. NO UNUSUAL MANIPULATION OF NEEDLE OCCURRED. PROCEDURE NOT ABORTED AS TESTING WAS FINE AND PLACEMENT APPEARED OPTIMAL. THE PROBE WAS NOT PLACED UNTIL AFTER CANNULA WAS PLACED." THE PATIENT WAS NOT INTERESTED IN HAVING THE RICE-SIZED FRAGMENT REMOVED BECAUSE IT WAS NOT PAINFUL. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389356 CURVED SHARP RF CANNULA, RADIOPAQUE MARKER STANDARD RF PROBES AND CANNULAS GXI AVANOS MEDICAL INC. PMF22-100-10CS 30229006 00193493986446

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male