BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X

    MDR report key: 7717252 · Received July 24, 2018

    Report

    Report Number
    3005075696-2018-00020
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    June 20, 2018
    Report Date
    August 14, 2018
    Manufacturer
    MAZOR ROBOTICS LTD.
    Product Code
    HAW
    UDI-DI
    07290109180465
    PMA / PMN Number
    K180307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017043. MAZOR ROBOTICS LTD. (MANUFACTURER - (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF MEDTRONIC NAVIGATION INC. (IMPORTER - (B)(4)).

    Description of Event or Problem · 0

    DURING A SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(4) (THAILAND), ON (B)(6) 2018 (REPORTED TO MAZOR ON (B)(6) 2018), WHILE SENDING THE SURGICAL ARM TO AP SCANNING POSITION THE ERROR 4059 "ARM SHIFT DETECTED JOINT 6" WAS DISPLAYED ON THE SCREEN. DEVICE MALFUNCTION RESULTED IN PROLONGATION OF THE SURGERY BY MORE THAN AN HOUR, WHILE THE PATIENT WAS ALREADY ANESTHETIZED. WHILE THE PATIENT DID NOT SUFFER ANY APPARENT DIRECT HARM, EXPOSURE OF THE PATIENT TO THE EFFECTS OF PROLONGED ANESTHESIA MIGHT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(6) HOSPITAL, ((B)(6)), ON (B)(6) 2018 (REPORTED TO MAZOR ON JUNE 25, 2018), WHILE SENDING THE SURGICAL ARM TO AP SCANNING POSITION THE ERROR 4059 "ARM SHIFT DETECTED JOINT 6" WAS DISPLAYED ON THE SCREEN. DEVICE MALFUNCTION RESULTED IN PROLONGATION OF THE SURGERY BY MORE THAN AN HOUR, WHILE THE PATIENT WAS ALREADY ANESTHETIZED. WHILE THE PATIENT DID NOT SUFFER ANY APPARENT DIRECT HARM, EXPOSURE OF THE PATIENT TO THE EFFECTS OF PROLONGED ANESTHESIA MIGHT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558545 MAZOR X STEREOTACTIC DEVICE HAW MAZOR ROBOTICS LTD. TPL0059 NA 07290109180465

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR