BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSDISCAL PROBE KIT

    MDR report key: 3826851 · Received February 28, 2014

    Report

    Report Number
    9710452-2014-00002
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    January 28, 2014
    Report Date
    February 27, 2014
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    GEI
    PMA / PMN Number
    K062937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD IS PENDING. IF ANY ADD'L RELEVANT INFO IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW, THE ADD'L RELEVANT INFO WILL BE SUBMITTED IN A FOLLOW-UP REPORT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MFR FOR ANALYSIS; THEREFORE, THE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS 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

    A REPORT WAS RECEIVED STATING THAT THE INSULATION FROM THE INTRODUCER PEELS BACK AND EXPOSES TOO MUCH ELECTRODE, POTENTIALLY RESULTING IN LESIONS OF UNWANTED SIZE OR LOCATION. THIS INCIDENT CAUSED THE GENERATOR TO DISPLAY AN ERROR MESSAGE, PREVENTING THE PROCEDURE FROM PROCEEDING. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PT IMPACT OR INJURY. PLEASE NOT THAT KIMBERLY-CLARK HEALTHCARE OWN THIS PRODUCT LINE, AND HAVE REPORTED AN MDR FOR THIS INCIDENT UNDER MFT REPORT NUMBER: 1033422-2014-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124757 TRANSDISCAL PROBE KIT RADIOFREQUENCY LESION PROBE KIT GEI BAYLIS MEDICAL CO., INC. TDK2-17-150-6 TTFA310513

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR