BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® STYLUS TRANSNASAL BUR

    MDR report key: 4492150 · Received February 6, 2015

    Report

    Report Number
    1045254-2015-00032
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Report Date
    December 18, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    PMA / PMN Number
    K081277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT: (1) 3MM MATCH FLUTED TRANSNASAL BUR (TN30MFL); LOT: 020866172; DATE OF MANUFACTURE: UNKNOWN (INVALID LOT#); 510K: K081277. (B)(4): IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, NO DEVICE WAS RECEIVED FOR EVALUATION¿AS IT WAS DISCARDED BY THE FACILITY. METHOD: NO TESTING METHODS PERFORMED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO 3MM MATCH FLUTED TRANSNASAL BURS BROKE DURING SURGERY. THERE WERE NO FRAGMENTS OR ANY PROCEDURES NECESSARY TO REMOVE ANY FRAGMENTS. THE DOCTOR WAS ABLE TO CONTINUE AND SUCCESSFULLY COMPLETE THE CASE. THIS IS THE ONLY INFORMATION PROVIDED AND THERE WAS ALSO NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88485 IPC® STYLUS TRANSNASAL BUR DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. TN30MFL 0208906253

    Patients

    Seq Age Sex Outcome Treatment
    1