BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISAO CURVED FINE DIAMOND BUR, 98MM X 1 MM

    MDR report key: 1150910 · Received September 3, 2008

    Report

    Report Number
    1045254-2008-00021
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 7, 2008
    Report Date
    September 3, 2008
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR IN QUESTION HAS NOT YET BEEN RETURNED FOR EVALUATION BY THE FILING DATE OF THIS REPORT. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION BY MEDTRONIC XOMED THAT THE PRODUCT(S) HEREIN ARE OR WERE DEFECTIVE OR DANGEROUS IN ANY RESPECT OR THE ANY CASUAL RELATIONSHIP EXISTS BETWEEN THESE PRODUCTS AND ANY ACTUAL OR POTENTIAL INJURY. IN ADDITION, THE SUBMISSION OF A REPORT BY MEDTRONIC XOMED SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS, IN FACT, OCCURRED.

    Description of Event or Problem · 1

    A MEDTRONIC SALES REP REPORTED FOR THE SURGEON THAT WHILE PERFORMING A COCHLEOSTOMY, A CURVED DIAMOND BUR WAS SELECTED AND PLACED INTO THE DRILL BY THE SCRUB NURSE. AS THE SURGEON POSITIONED THE BUR INTO THE SURGICAL FIELD AND VISUALIZED THE TIP OF THE BUR THROUGH HIS MICROSCOPE, HE OBSERVED THAT THE DISTAL DRILLING TIP WAS MISSING. THE SURGEON AND SURGICAL TEAM SPET APPROX. 15 MINUTES LOOKING FOR THE TIP TO BE CERTAIN THAT IT HAD NOT BROKEN OFF IN THE SURGICAL FIELD, BUT WERE NOT ABLE TO LOCATE IT. THE SURGEON CAN ONLY CONCLUDE THAT IT WAS EITHER MISSING PRIOR TO BEING TAKEN OUT THE PACKAGING, OR BROKE OFF DURING MOUNTING INTO THE DRILL. THERE WAS NO RECORDED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISAO CURVED FINE DIAMOND BUR, 98MM X 1 MM DRILL BUR EQJ MEDTRONIC XOMED, INC. 31181098E 55361900

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other