BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLUS TRANSNASAL BUR

    MDR report key: 3944786 · Received July 18, 2014

    Report

    Report Number
    1045254-2014-00154
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K081277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4): THE BUR WAS RECEIVED FOR EVALUATION. AS RECEIVED CONDITION: RECEIVED ONE (1) SAMPLE WITHOUT THE ORIGINAL PRODUCT PACKAGING. THE LABEL STICKER ON THE GREY MOLDED HUB OF THE BUR IDENTIFIED PART NUMBER AS REF: (B)(4). THE POUCH LABEL WAS NOT AVAILABLE TO IDENTIFY LOT NUMBER. THE CONDITION OF THE DEVICE DID NOT SHOW CUSTOMER USE AS THERE WAS NO PRESENCE OF BIO-RESIDUE OR VISIBLE DAMAGE ON THE SAMPLE. EQUIPMENT USED: IPC (SN: (B)(4), REF: (B)(4)) AND EM200 HANDPIECE (SN: (B)(4)). OBSERVATIONS: UPON VISUAL EVALUATION, NO DAMAGE WAS NOTICED ON THE PRODUCT IN ANY MANNER. THE BUR TIP REMAINED INTACT AT THE DISTAL END OF THE SHAFT. THE OUTER SHAFT WAS FREE OF DAMAGE. THE BUR TANG INSIDE THE GREY HUB WAS ALSO INTACT AND FREE OF DAMAGE. THE DEVICE WAS FUNCTIONALLY EVALUATED WITH AN INTEGRATED POWER CONSOLE (IPC) UNIT AND HANDPIECE AND WAS FOUND TO FUNCTION (OSCILLATE) WITHOUT ANY ISSUES. THE DEVICE WAS FUNCTIONALLY TESTED AT VARYING SPEEDS. IN CONCLUSION, NO FAULT WAS FOUND WITH THE DEVICE AS IT MET ALL PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿TNSB [TRANS NASAL SKULL BASE BUR] WAS USED WITH NAVI DURING ENDOSCOPIC EXTIRPATION OF TRANSNASAL PITUITARY TUMOR, WHICH RESULTED IN EXCESSIVE BLEEDING. THOUGH THE TUMORECTOMY WAS NOT COMPLETED, THE PROCEDURE WAS SUSPENDED AND CLOSED A SURGICAL INCISION BECAUSE HEMOSTASIS WAS PRIORITIZED. ON THE NEXT DAY, THE SALES REP CONFIRMED THAT IT WAS SUCCESSFUL IN HEMOSTASIS AND THE PATIENT RECOVERED. ACCORDING TO THE DOCTOR¿S OPINION, THERE WAS A HIGH POSSIBILITY THAT BLEEDING WOULD HAVE BEEN CAUSED BY THE OPERATION RATHER THAN DEVICE FAILURE SUCH AS DRILL. THE PATIENT HAD THIN BONE AND CONDUCT OF AUTOPSY WAS COMPLICATED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422764 STYLUS TRANSNASAL BUR DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. TN40RCD 0207287767

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention