BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X STEALTH EDITION

    MDR report key: 12094739 · Received June 30, 2021

    Report

    Report Number
    3005075696-2021-00080
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 30, 2021
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109183213
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: KIT0929-01, SERIAL/LOT #: NONE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE OPEN/CLOSE SWITCHES ON THE CYLINDER WERE REPLACED, THE OPEN AND CLOSE PRESSURE WAS ADJUSTED AND THE ROD ENDS OF THE CYLINDERS WERE ADJUSTED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE 3DEFINE CAMERA LENS PIECE WAS REPLACED WITH ANOTHER ONE THAT WAS BROKEN. THE MANUFACTURER REPRESENTATIVE KNEW THIS BECAUSE THEIR OLD ONE HAD A CHUNK MISSING OUT OF IT BUT WORKED FINE, THE NEW ONE DOES NOT ALLOW THE DRAPE TO CLASP ON. IT WAS ALSO REPORTED THAT THE GUIDANCE SYSTEM WAS DIFFICULT TO MOVE SPECIFICALLY WHEN TRYING TO PUT IT INTO STORAGE POSITION. THE MANUFACTURER REPRESENTATIVE HAD TO USE FULL BODY WEIGHT TO STORE THE GUIDANCE SYSTEM. THE DOOR WOULD NOT CLOSE DUE TO SENSOR ERRORS SINCE IT WAS DIFFICULT TO PUT INTO THE STORAGE POSITION. IT WAS ALSO REPORTED THAT THE SYSTEM WAS STUCK IN PROCESSING. THE MANUFACTURER REPRESENTATIVE ATTEMPTED A HARD REBOOT. LASTLY, IT WAS REPORTED THAT THE HOOD DID NOT OPEN CORRECTLY. AN ERROR POPPED UP AND THEN THEY HAVE TO LIFT IT ALL THE WAY UP AND PRESS THE BUTTON. IT WOULD THEN SLAM DOWN VERY QUICKLY AND FUNCTION CORRECTLY AFTER THAT. NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987437 MAZOR X STEALTH EDITION ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109183213

    Patients

    Seq Age Sex Outcome Treatment
    1