BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOFREQUENCY PROBE-CURVED

    MDR report key: 3646596 · Received January 7, 2014

    Report

    Report Number
    9710452-2014-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    December 9, 2013
    Report Date
    January 7, 2014
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    GXI
    PMA / PMN Number
    K002389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD IS PENDING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A FOLLOW UP REPORT. THE DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS; THEREFORE, A ROOT CAUSE FOR THIS REPORTED EVENT COULD NOT BE DETERMINED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED BY THE MFR INDICATING THAT THE PROBE WAS NOT WORKING PROPERLY DURING AN RF PROCEDURE. ERROR WINDOWS WERE OBSERVED ON THE PAIN MANAGEMENT GENERATOR AND THE PHYSICIAN WAS UNABLE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS ABORTED. THERE WAS NO INDICATION OF PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION. PLEASE NOTE THAT KIMBERLY-CLARK HEALTHCARE OWNS THIS PRODUCT LINE, AND HAVE REPORTED AN MDR FOR THIS INCIDENT UNDER MFR REPORT NUMBER: 1033422-2014-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10889 RADIOFREQUENCY PROBE-CURVED RADIOFREQUENCY PROBE GXI BAYLIS MEDICAL CO., INC. PMP-20-145C PPFB220711

    Patients

    Seq Age Sex Outcome Treatment
    1