BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLEABLE SUCTION MEDIUM, ANGLE TIP

    MDR report key: 4821529 · Received June 5, 2015

    Report

    Report Number
    1723170-2015-00670
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 7, 2015
    Report Date
    February 19, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    PGW
    PMA / PMN Number
    K133665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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-2016. 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-2016. 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 IDENTIFIER FIELD NOT SUFFICIENT TO HOLD ALL DIGITS, SHOULD READ: (B)(4). SUSPECT SUCTION INSTRUMENT WAS DISCARDED BY THE SITE. DISCARDED BY SITE.

    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.¿

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) A NAVIGATED SUCTION INSTRUMENT STOPPED TRACKING. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364280 MALLEABLE SUCTION MEDIUM, ANGLE TIP EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NI 141010F

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR