BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13 CM TRICUT BLADE

    MDR report key: 4937119 · Received July 23, 2015

    Report

    Report Number
    1723170-2015-00908
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 25, 2015
    Report Date
    February 18, 2016
    Manufacturer
    MEDTRONIC ENT (JACKSONVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K130608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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

    PATIENT INFORMATION WAS NOT MADE AVAILABLE FROM THE SITE. THE 510(K) IS K130608. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A MEDTRONIC REPRESENTATIVE REPORTED THAT THE PROCEDURE WAS A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE SURGEON DID NOT PRECISELY MEASURE THE ALLEGED INACCURACY. HE FELT THE INACCURACY WAS GREATER THAN 2 MM. THE INCIDENT CAUSED A 15 MIN DELAY DURING NAVIGATION. THE SURGERY CONTINUED WITH NAVIGATION AFTER CHANGING TO ANOTHER EM BLADE. THE NAVIGATION WAS ACCURATE WITH THE SWITCHED INSTRUMENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CAUSE OF THE ISSUE WAS UNKNOWN. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE BLADE WAS CONNECTED TO A TEST SYSTEM FOR A MULTI-DAY BURN-IN TEST. REGISTRATION, NAVIGATION AND ACCURACY LOOK NORMAL. THE DEVICE REMAINED IN GREEN STATUS DURING TESTING. THE BLADE PASSED THE ACCURACY TEST AND WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A EAR, NOSE & THROAT (ENT) AN ALLEGED INACCURACY OCCURRED WHEN USING THE EM BLADE. NO FURTHER DETAILS REGARDING THE CONCERN WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480418 13 CM TRICUT BLADE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC ENT (JACKSONVILLE) NI 0207897805

    Patients

    Seq Age Sex Outcome Treatment
    1