BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE SYSTEM - EU PLUG E

    MDR report key: 14467958 · Received May 23, 2022

    Report

    Report Number
    3009185973-2022-00031
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 20, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT AN INACCURACY IS CONFIRMED FOR THE TEN ELECTRODES, BETWEEN 4.7 MM AND 6.5 MM. THIS INACCURACY IS DUE TO A FUSION ERROR BETWEEN THE REGISTRATION CT AND THE PLANNING CT. THE USER SHOULD HAVE VERIFIED THE FUSION AND MANUALLY RE-ADJUSTED IT BEFORE VALIDATION. FURTHERMORE, THE PLANNING CT HAD A SLICE THICKNESS OF 3 MM, WHICH IS OVER THE RECOMMENDATIONS OF THE ACQUISITION PROTOCOL, AND CAN IMPACT THE QUALITY OF THE AUTOMATIC FUSION. THE ROBOT WAS ACCURATE IN REGARD TO THE REGISTRATION EXAM. THE USER ALTERED THE LEKSELL FRAME BY DRILLING MARKERS IN IT, WHICH IS AGAINST THE RECOMMENDATIONS AND CAN IMPACT THE RELIABILITY OF THE DEVICE. UDI# : (B)(4).

    Description of Event or Problem · 0

    THE SURGEON FIXED THE PATIENT IN THE LEKSELL FRAME AND ADDED SOME ADDITIONAL MARKERS ON THE LEKSELL FRAME. FIRST ATTEMPT OF REGISTRATION, THE MARKERS WERE TO LOOSE, SO HE DECIDED TO PUT SOME WAX. THEN THE MARKERS WERE STABLE ENOUGH FOR HIM. FUSION BETWEEN THE AIRO IMAGE AND THE CT DID NOT GIVE A GOOD RESULT. THEY ADJUSTED MANUALLY, TRIED SEVERAL TIMES WITH LESS SLICES, DUE TO ARTEFACTS FROM THE LEKSELL FRAME HOLDER. FINALLY HE CONFIRMED THE FUSION AND SET MARKERS IN THE IMAGE. THE REGSITRATION ERROR WAS NOT IDEAL WITH 0,96 MM, BUT STILL RATED GREEN. VERIFICATION WAS DONE. ACCURACY ON THE AIRO IMAGE WAS OK. THE SURGEON SENT THE ROBOT TO THE TRAJECTORY X PUT IN A ROD AND TOOK ANOTHER CT WITH THE AIRO. THIS TIME THE FUSION WAS CONFIRMED QUICKER. ALL SCEWS/ANCHORS WERE IMPLANTED AND THEN ALL ELECTRODES WERE IMPLANTED AT THE END OF THE SURGERY. POST-OPERATIVE CT SHOWED AN ENTRY POINT ERROR OF 4 MM WHILE THE TARGET POINT ERROR WAS AROUND 1 MM. THE ENTRY POINT ERROR WAS FOUND TO BE DUE TO A ROTATIONAL ERROR IN THE FUSED AIRO CT, WHICH WAS USED FOR REGISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618238 ROSA ONE SYSTEM - EU PLUG E COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS ROSA ONE 3.1 3.1.5.28

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown