BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT SUCTION, AXIEM¿

    MDR report key: 3090006 · Received May 2, 2013

    Report

    Report Number
    1723170-2013-00306
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON FOLLOW UP #1, THESE FIELDS WERE POPULATED WITH THE WRONG DATE. THE CORRECT DATE IS NOW PROVIDED.

    Additional Manufacturer Narrative · 1

    PROVIDED CORRECT LOT NUMBER AND DEVICE MANUFACTURER DATE.

    Additional Manufacturer Narrative · 1

    A NEW SUCTION WAS ORDERED BY THE SITE THROUGH CUSTOMER SERVICE INSTEAD OF THE RETURN MATERIALS AUTHORIZATION PROCESS (RMA). A RETURN ITEM ONLY RMA WAS CREATED, BUT THE PART WAS NEVER RETURNED FOR ANALYSIS DESPITE MULTIPLE ATTEMPTS TO RETRIEVE IT. ALTHOUGH THE SITE RECEIVED THE NEW SUCTION THEY FAILED TO REMOVE THE SUSPECT SUCTION FROM USE. A MEDTRONIC REPRESENTATIVE DISCOVERED THIS AND REMOVED THE SUCTION FROM USE AS OF (B)(6) 2013. FURTHERMORE, A SUCCESSFUL PREVENTATIVE MAINTENANCE AND SYSTEM CHECKOUT WERE PERFORMED ON THE SYSTEM. NO FURTHER ISSUES REPORTED SINCE SUCTION LOT#12652 REMOVED FROM USE.

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS UNKNOWN AT THIS TIME. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE INSTRUMENTS. ALL OF THE INSTRUMENTS VERIFIED NORMALLY EXCEPT THE STRAIGHT SUCTION REPORTED IN THE EVENT. THE STRAIGHT SUCTION WOULD NOT VERIFY WITH EITHER EMITTER AT THE SITE. THE DISTANCE TO DIVOT ERROR WAS FOUND TO BE AROUND 5+MM WHICH SUGGESTS THAT THE INSTRUMENT WAS BENT. BASED ON THESE FINDINGS, THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS THE USE OF A PHYSICALLY DAMAGED INSTRUMENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SURGEON REGISTERED THE PATIENT FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) CASE WITH TRACER REGISTRATION. THEY PASSED THE REGISTRATION ON THE FIRST TRY. HE CHECKED ACCURACY WITH THE TRACER PROBE. ABOUT 15 MINUTES LATER HE SWITCHED TO THE STRAIGHT SUCTION AND THEN SHOWED THE REP THAT IT WAS INACCURATE BOTH ON THE TIP OF THE NOSE AND IN THE SINUSES BY 1CM POSTERIORLY. THEY RE-REGISTERED AND AGAIN CHECKED ACCURACY. ABOUT 45 MINUTES LATER WITH THE STRAIGHT SUCTION HE WAS INACCURATE AGAIN. THE TRACKING DETAILS SHOWED THE GEOMETRY ERROR FOR THE INSTRUMENT BETWEEN .3-.5MM. THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH THE USE OF NAVIGATION WITH NO NEGATIVE IMPACT TO THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192884 STRAIGHT SUCTION, AXIEM¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 70003700

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR