BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIOFREQUENCY NITINOL PROBE-CURVED

    MDR report key: 3232286 · Received July 12, 2013

    Report

    Report Number
    9710452-2013-00008
    Event Type
    Other
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 12, 2013
    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. ON SAMPLE WAS RETURNED. SAMPLE REVIEW IS CURRENTLY ONGOING. 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

    DURING A PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY WHEN TRYING TO REMOVE THE PROBE FROM THE PATIENT. WHEN THE PHYSICIAN PULLED ON THE PROBE IN AN ATTEMPT TO REMOVE IT, THE 'SHEATH' OF THE PROBE WAS STRIPPED OFF. THERE WAS NO REPORTED PATIENT INJURY. PLEASE NOTE THAT KIMBERLY-CLERK HEALTHCARE OWNS THIS PRODUCT LINE, AND HAVE REPORTED AN MDR FOR THIS INCIDENT UNDER MFR REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322274 RADIOFREQUENCY NITINOL PROBE-CURVED PROBE GXI BAYLIS MEDICAL CO., INC. PMP-100C-N PNFZ110113

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR