BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLADE 1884012EM RAD12 4MM M4 ROTATABLE

    MDR report key: 1403320 · Received June 10, 2009

    Report

    Report Number
    1045254-2009-00018
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    May 11, 2009
    Report Date
    May 14, 2009
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDWATCH FORM WAS NOT RECEIVED FROM THE REPORTER THEREFORE, ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED OR RELEASED BY THE REPORTER DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFO. IT WAS REPORTED THAT NO ADDITIONAL OR FOLLOW-UP PROCEDURES WERE PERFORMED ON THE PATIENT AS A RESULT OF THIS EVENT. THE PATIENT DID NOT LEAVE THE OPERATING ROOM WITH A CEREBRAL SPINAL FLUID LEAK, AND IS DOING WELL WITH NO ISSUES CURRENTLY. THE BLADE WAS DISCARDED AFTER SURGERY THEREFORE, AN ANALYSIS WAS NOT PERFORMED. A TEST OF THE IMAGE-GUIDED SYSTEM WAS PERFORMED AT THE HOSPITAL WITH NO FAULT FOUND. A REVIEW OF THE MANUFACTURING DOCUMENTS SHOWED ALL BLADES OF THIS LOT WERE SUCCESSFULLY CALIBRATED. ADDITIONAL TRAINING ON PROPER USE AND TECHNIQUE WAS PROVIDED TO THE OPERATING ROOM STAFF AT THE HOSPITAL, BEFORE AND AFTER THE EVENT, BY MEDTRONIC NAVIGATION. THE IFU STATES THE FOLLOWING "THE SYSTEM AND ITS ASSOCIATED APPLICATIONS SHOULD BE USED ONLY AS AN ADJUNCT FOR SURGICAL GUIDANCE. THEY DO NOT REPLACE THE SURGEON'S KNOWLEDGE, EXPERTISE, OR JUDGEMENT. IF SYSTEM NAVIGATION SEEMS INACCURATE AND STEPS TO RESTORE ACCURACY ARE UNSUCCESSFUL, ABORT USE OF THE SYSTEM." PATIENT REGISTRATION AND TRACING ESTABLISH THE LOCATION AND ORIENTATION OF THE INSTRUMENT WITH RESPECT TO INDIVIDUAL PATIENT ANATOMY. NAVIGATION ACCURACY IS TO BE CONFIRMED PERIODICALLY DURING THE PROCEDURE. THE IFU GIVES CLEAR INSTRUCTIONS AND A PICTORIAL REPRESENTATION OF THE TRACKING PATH FOR REGISTERING THE PATIENT. HOWEVER, THE DOCTOR ONLY PERFORMED A PARTIAL TRACE "MID-BROW TO MID-BROW" TO REGISTER THE PATIENT WHICH IS NOT IN ACCORDANCE WITH THE LABELING (IFU). AFTER REGISTRATION, THE USER EITHER ACCEPTS THE ACCURACY OR RE-REGISTERS BEFORE PROCEEDING WITH NAVIGATION. THE REGISTRATION PROCESS, PER THE IFU, WILL ALLOW UP TO A 5MM VARIANCE. AS REPORTED BY THE DOCTOR, THE TRACKING LOOKED GOOD SUPERFICIALLY, BUT WAS INACCURATE DEEP IN THE SINUS BY 2MM TO 5MM. THE DOCTOR ALSO STATED THAT HE WAS NAVIGATING THE TRACKING BLADE, BUT THAT HE WAS NOT ACTIVELY NAVIGATING WHEN THE INJURY OCCURRED. THE ENT NURSE HAD REQUESTED THAT THE DOCTOR RETRACE DUE TO A LIMITED NUMBER OF REGISTRATION POINT ON THE SIDE OF THE PATIENT'S HEAD, BUT HE DECLINED. NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD. WILL CONTINUE TO MONITOR AND REPORT TRENDS. REFERENCE ALSO (B)(4) MDR NUMBER 1723170-2009-00007.

    Description of Event or Problem · 1

    THE IMAGE-GUIDED TRACKING OF THE SINUS BLADE WAS OFF BY 2 MM. AS A RESULT, PATIENT IMPACT WAS REPORTED WHEN THE DURA WAS NICKED BY THE BLADE. PATIENT IS STABLE AND RECOVERING. THE DR ALSO ADDED "THERE APPEARED TO BE MAGNETIC INTERFERENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE 1884012EM RAD12 4MM M4 ROTATABLE NONE ETN MEDTRONIC XOMED, INC. 1884012EM 61655400

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other