BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT SUCTION, AXIEM

    MDR report key: 4973336 · Received August 5, 2015

    Report

    Report Number
    1723170-2015-00964
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 13, 2015
    Report Date
    February 17, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THE SUCTION TOOL FAILED NAVIGATION WITH AN ERROR OF 2.2MM. THE CAUSE OF THE REPORTED EVENT WAS PHYSICAL DAMAGE TO THE INSTRUMENT. A REVIEW OF THE DEVICE MANUFACTURING RECORDS SHOWED NO ANOMALIES. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. THE SITE CHOSE NOT TO REPLACE THE DEVICE AS THEY HAD AN EXTRA ONE FROM INVENTORY.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT MADE AVAILABLE FROM THE SITE. DEVICE LOT NUMBER NOT AVAILABLE. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER, THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND TESTED THE SUSPECT INSTRUMENT. THE SUCTION WAS DIFFICULT TO VERIFY AND THE ALLEGED INACCURACY WAS REPLICATED DURING TESTING. THE REP ENCOURAGED THE SITE TO PURCHASE A NEW SUCTION AND TAGGED THE SUSPECT INSTRUMENT AS DAMAGED. SUSPECT SUCTION HAS NOT BEEN RECEIVED FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS DISCOVERED ON 27-JAN-2016, THAT AN INCORRECT DATE WAS REFERENCED IN A PREVIOUS SUPPLEMENTAL 3500A SUBMISSION. THE REPORTED DATE OF 16-AUG-2016 WAS REPORTED INCORRECTLY AND SHOULD BE 16-AUG-2015.STATEMENT IN PREVIOUS SUPPLEMENTAL 3500A SUBMISSION SHOULD READ: ¿ON 30-JUN-2015, IT WAS NOTICED THAT A CODING ERROR IN MDR SUBMISSIONS FROM OUR FACILITY RESULTED IN THE MAUDE DATABASE INCORRECTLY CODING THE DEVICES RELATED TO OUR MDR SUBMISSIONS FROM 25-MAY-2015 TO 16-AUG-2015. THE DECISION TO WAIT UNTIL THE DATABASE WAS CORRECTED WAS MADE AFTER CONSULTATION WITH THE FDA AS ADVISED BY A CONSUMER SAFETY OFFICER WITH THE INFORMATION ANALYSIS BRANCH, DIVISION OF POST MARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS. AN IT SOLUTION WAS IMPLEMENTED ON 16-AUG-2015. THIS MDR WAS SUBMITTED TO CORRECT THE CODING ERROR. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION AND/OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.¿

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    A SITE BIOMED REPRESENTATIVE REPORTED THAT WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE SURGEON HAD DIFFICULTY REGISTERING THE PATIENT. TRACKING WOULD GO IN AND OUT OF RED STATUS. AFTER THE PATIENT WAS SUCCESSFULLY REGISTERED, THE SURGEON DEEMED BEING INACCURATE IN THE SUPERIOR DIRECTION. SPECIFIC MEASUREMENT WAS NOT KNOWN. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513380 STRAIGHT SUCTION, AXIEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1