BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINERGY COOLED RADIOFREQUENCY PROBE

    MDR report key: 3019389 · Received March 18, 2013

    Report

    Report Number
    9710452-2013-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    GXI
    PMA / PMN Number
    K053082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE (SIP-17-75-4) AND COMPANION INTRODUCER WERE RETURNED TO THE MFR FOR ANALYSIS. THE PROBE WAS TESTED IN THE LABORATORY AND PASSED TEMPERATURE TESTS (ROOM TEMPERATURE, TIP TEMPERATURE, HI SETPOINT TEMPERATURE), ELECTRONIC FUNCTION (CONTINUITY), AND PAIN MANAGEMENT GENERATOR (PMG) FUNCTION. THE TESTING ON THE INTRODUCER IS ONGOING. IF ANY ADD'L RELEVANT INFO IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW OR ONCE SAMPLES ARE EVALUATED, THE ADD'L RELEVANT INFO WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. AS PER THE DIRECTIONS FOR USE, THE SINERGY COOLED RADIOFREQUENCY (RF) KIT, IN COMBINATION WITH THE RADIOFREQUENCY (RF) GENERATOR (PMG-115-TD/PMG-230-TD) IS INDICATED FOR USE TO CREATE RF LESIONS IN NERVOUS TISSUE. INFO FOR 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 PROCEDURE USING THE SINERGY PROBE KIT TO TREAT A PT SUFFERING FROM AN OSTEOID OSTEOMA IN THE MARGO INTERIOR OF THE LEFT TIBIA, THE PROBE OVERHEATED. THE PT SUFFERED TISSUE SCARRING. THE PROCEDURE WAS ABORTED. PLEASE NOTE THAT KIMBERLY-CLARK HEALTHCARE OWNS THIS PRODUCT LINE, AND HAVE REPORTED AN MDR FOR THIS INCIDENT UNDER MFR REPORT NUMBER: 1033422-2013-00011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112744 SINERGY COOLED RADIOFREQUENCY PROBE RADIOFREQUENCY PROBE GXI BAYLIS MEDICAL CO., INC. SIP-17-75-4 SPFA180708

    Patients

    Seq Age Sex Outcome Treatment
    1