BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOFREQUENCY PROBE KIT

    MDR report key: 2852404 · Received November 13, 2012

    Report

    Report Number
    9710452-2012-00005
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 13, 2012
    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

    WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS THE LOT NUMBER PROVIDED FOR THE DEVICE INVOLVED IN THE REPORTED EVENT IS INCOMPLETE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT A VALID LOT NUMBER OR RETURNED DEVICE WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS, ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADD¿L INVESTIGATIONS.

    Description of Event or Problem · 1

    DURING A RF PROCEDURE, THE PROBE SEPARATED FROM THE HANDLE. THE PROBE WAS REMOVED AND EXCHANGED FOR A DIFFERENT ONE, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THERE WAS NO INJURY TO THE PT. THE PROBE THAT WAS SEPARATED FROM THE HANDLE HAS BEEN DISPOSED OF. PLEASE NOTE THAT KIMBERLY-CLARK HEALTHCARE OWNS THIS PRODUCT LINE, AND HAVE REPORTED AN MDR FOR THIS INCIDENT UNDER MFR REPORT NUMBER: 1033422-2012-00022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOFREQUENCY PROBE KIT PROBE, CONNECTOR CABLE GXI BAYLIS MEDICAL CO., INC. PMK-20-145

    Patients

    Seq Age Sex Outcome Treatment
    1