BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION TITANIUM PHOTON BIPOLAR BAYONET

    MDR report key: 3560367 · Received December 6, 2013

    Report

    Report Number
    3007208013-2013-00018
    Event Type
    Injury
    Date Received
    December 6, 2013
    Date of Event
    November 5, 2012
    Report Date
    December 4, 2013
    Manufacturer
    TITAN
    Product Code
    GZX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS SHIPPED ON 10/21/2011 TO (B)(6). THIS PRODUCT PRIVATELY LABELED PER 21 CFR PART 807.85. THE ORIGINAL MFR IS TITAN MANUFACTURING. THE PRODUCT AND ALL OF THE INFORMATION WILL BE SENT TO TITAN MANUFACTURING FOR INVESTIGATION. TITAN MANUFACTURING WAS INFORMED FOR THE ISSUE AND SYMMETRY SURGICAL RECEIVED A RESPONSE FROM THEIR QUALITY DEPARTMENT ON 12/11/2012. SEE BELOW RESPONSE FROM (B)(4) DATED 12/11/2012. RECEIVED EVALUATION FROM TITAN MANUFACTURING STATING THE FOLLOWING: I DO NOT SEE ANYTHING WRONG WITH THE PRODUCT, IT LOOKS AS IF IT IS IN PERFECT WORKING CONDITION. I DID NOTICE THAT THE CUSTOMER HAS ALTERED THE ORIGINAL PRODUCT WITH SOME IDENTIFICATION MARK WHICH MAY BE SOME FORM OF BAR CODE BUT I HAVE NO KNOWLEDGE OF HOW OR WHY THIS WAS DONE. OUR SERIAL NUMBER SYSTEM NUMBER IS IN PLACE AND CAN BE TRACED BACK TO ORIGINAL BEGINNING PRODUCTION DATE SO THAT THERE WOULD BE NO REASON FOR ALTERING THIS PRODUCT. PLEASE NOTE THAT ALTERING A PRODUCT THAT IS FDA APPROVED AND 510K BY TITAN YOU ARE VOIDING ALL WARRANTIES AND RETURNS FOR ANY REASON. PLEASE NOTE THAT THIS FORCEP IS 100 PERCENT ACTIVE THROUGH BOTH FORCEP ARMS WITH ELECTRICITY WHEN THE PRODUCT IS ACTIVATED BY THE FOOT PEDDLE. THE PROBLEM WITH THIS FORCEP BASED ON OUR CUSTOMERS RESPONSE SOUNDS LIKE THE END USER SHOULD HAVE USED A PRODUCT THAT WAS FULLY INSULATED EXCEPT FOR 8 TO 10MM OF THE TIP BEING EXPOSED. HUMAN ERROR IN CHOOSING THE INCORRECT TOOL FOR THE PROCEDURE THAT WAS BEING PERFORMED.

    Description of Event or Problem · 1

    PRODUCT HAD AN ABNORMAL THERMAL SPREAD OR ARCING WHICH BURNED A PATIENT'S SPINAL NERVE ROOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634169 CAREFUSION TITANIUM PHOTON BIPOLAR BAYONET TITANIUM PHOTON BIPOLAR BAYONET GZX TITAN 08-0509 TK10070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other