BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EM ENT STRAIGHT SUCTION

    MDR report key: 10779685 · Received November 3, 2020

    Report

    Report Number
    1723170-2020-02872
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 14, 2020
    Report Date
    January 6, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: CODES B01 (10), C07 (180) AND D02 (4307) WERE APPLIED TO THE HARDWARE ANALYSIS IN THE PREVIOUS REPORT, HOWEVER THE CODES WERE NOT ADDED TO H6. ADDING CODES IN H6. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE STRAIGHT SUCTION WAS RETURNED, BUT HAS NOT BEEN ANALYZED. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE STRAIGHT SUCTION WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED STRAIGHT SUCTION HAD DIFFICULTY VERIFYING WHEN ATTACHED TO A KNOWN GOOD TRACKER DISPLAYING A DIVOT ERROR OF 1.4 MM TO 2.0 MM. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT THAT WAS USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE STRAIGHT SUCTION COULDN'T BE VERIFIED WELL. THERE WAS NO REPORTED DELAY OR KNOWN IMPACT ON PATIENT OUTCOME. ON (B)(6) 2020 (REP, FOR): IT WAS REPORTED THAT THE INSTRUMENT WAS DIFFICULT TO VERIFY. EVENTUALLY, THE INSTRUMENT WAS VERIFIED AND THE PROCEDURE WAS COMPLETED USING IT. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246607 EM ENT STRAIGHT SUCTION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733449 200117

    Patients

    Seq Age Sex Outcome Treatment
    1