BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOFREQUENCY PROBE-CURVED

    MDR report key: 2864510 · Received December 6, 2012

    Report

    Report Number
    9710452-2012-00006
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 9, 2012
    Report Date
    December 6, 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

    THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS PENDING. ANY ADDITIONAL RELEVANT INFO IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. 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 ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    DURING AN RF PROCEDURE, THE RF NEEDLE OF THE PROBE BROKE. THERE WAS NO INJURY TO THE PT. PLEASE NOTE THAT KIMBERLY-CLARK HEALTHCARE OWNS THIS PRODUCT LINE, AND HAVE REPORTED AN MDR FOR THIS INCIDENT UNDER MANUFACTURER REPORT NUMBER: 1033422-2012-00027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOFREQUENCY PROBE-CURVED PROBE GXI BAYLIS MEDICAL CO., INC. PMC-20-100C PPFA101210

    Patients

    Seq Age Sex Outcome Treatment
    1