BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION COMPACT

    MDR report key: 10922978 · Received November 30, 2020

    Report

    Report Number
    1723170-2020-03125
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    November 6, 2020
    Report Date
    January 4, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    PGW
    PMA / PMN Number
    K153247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS ON THE RETURNED EMITTER CABLE HAS NO FAILURE FOUND WHEN ANALYZED. ANALYSIS STATES THAT IT PASSED CONTINUITY TEST WITH NO OPENS OR SHORTS. CONTINUATION OF CONCOMITANT MEDICAL PRODUCT: PN: 9735546, LOT #: 191114. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE EMITTER SYSTEM, EMITTER CABLE AND EMITTER GENERATOR WAS REPLACED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. NO DEVICES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. DEVICE MANUFACTURING DATE IS UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 9660651. PRODUCT ID: 9731203. PRODUCT ID: 9735546. 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 DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE REGISTRATION WAS COMPLETED WITHOUT ANY PROBLEMS. AN ATTEMPT WAS MADE TO USE THE DEVICE IN A STERILE FIELD, BUT THE INSTRUMENT WAS NOT RECOGNIZED AND THE EMITTER WAS NOT CONNECTED ON THE EQUIPMENT SCREEN. A REBOOT WAS PERFORMED AND CALL CABLES WERE RECONNECTED WITHOUT RESOLUTION. THE SITE DISCONTINUED NAVIGATION TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385066 FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT PGW MEDTRONIC NAVIGATION, INC 9735602

    Patients

    Seq Age Sex Outcome Treatment
    1