BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 13993383 · Received April 4, 2022

    Report

    Report Number
    3009185973-2022-00025
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 1, 2022
    Report Date
    July 22, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #:(B)(4).

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT THE ROBOT OPERATED AS EXPECTED AND THE TRAJECTORIES WERE PROPERLY PLACED IN RELATION TO THE REGISTERED EXAM ALTHOUGH THAT THE REGISTRATION ACCURACY WAS NOT CHECKED AS RECOMMENDED ON THE INSTRUCTIONS FOR USE. HOWEVER, THE FUSION ANALYSIS REVEALED THAT THE REGISTERED EXAM MERGED TO THE MRI PLAN WAS VALIDATED WITH ROTATIONAL ERRORS ON MULTIPLE PLANES. THEREFORE, THE INACCURATE PLACEMENT OF THE ELECTRODES IN THE BRAIN IS CONFIRMED FOR THE MOST ANTERIOR ONES. THE AUTOMATIC FUSION DID NOT PROVIDE A CORRECT RESULT AND REQUIRED TO BE RE-ADJUSTED. ALTHOUGH THAT THE DEVICE WORKED WITHIN SPECIFICATIONS, THIS ISSUE WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS. THE RECALCULATE FUNCTION WAS USED TO GET A BETTER RESULT AND HELPED ON THAT PURPOSE BUT THE RESULT WAS NOT RE-ADJUSTED AGAIN AND VALIDATED WITH ROTATIONAL ERRORS. THIS IS THE CAUSE FOR THE INACCURACIES OBSERVED.

    Description of Event or Problem · 0

    THE SURGEON HAD A MERGE ISSUE ON (B)(6) 2022. O-ARM SCAN WAS TAKEN AFTER FIDUCIALS WERE PLACED AND IT WAS MERGED TO AN MR SCAN. THE O-ARM CT CAME OVER WITH INCORRECT ORIENTATIONS IN EACH ANATOMICAL PLANE (THE SLICES AND PLANES DID NOT CORRELATE). THE O-ARM SCAN HAD TO BE ROTATED TO GET IT TO THE CORRECT ORIENTATION, THE MERGE WAS RECALCULATED, AND IT LOOKED GOOD ENOUGH FOR SURGEON APPROVAL. REGISTRATION HAD RMS OF 0.42. PROCEDURE WAS CONDUCTED WITHOUT ANY NAVIGATION ISSUES. THE SURGEON OFFICE REVIEWED THE ACCURACY BY MERGING THE POST OPERATIVE CT TO THE PRE OPERATIVE PLAN ON MR. 13/16 LEADS WERE OFF TRAJECTORY ACCORDING TO POST OPERATIVE CT TO PLAN MERGE. EVERY ERRANT LEAD WAS GOOD LENGTH AND FOLLOWED TRAJECTORY PATH BUT WAS TRANSLATED 2-3MM TO THE SIDE. NO COMMON PATTERN OF THESE LEADS BEING OFF IN ONE DIRECTION OR PLANE WAS FOUND. IT WAS SPORADIC.

    Description of Event or Problem · 0

    THE SURGEON HAD A MERGE ISSUE ON (B)(6) 2022. O-ARM SCAN WAS TAKEN AFTER FIDUCIALS WERE PLACED AND IT WAS MERGED TO AN MR SCAN. THE O-ARM CT CAME OVER WITH INCORRECT ORIENTATIONS IN EACH ANATOMICAL PLANE (THE SLICES AND PLANES DID NOT CORRELATE). THE O-ARM SCAN HAD TO BE ROTATED TO GET IT TO THE CORRECT ORIENTATION, THE MERGE WAS RECALCULATED, AND IT LOOKED GOOD ENOUGH FOR SURGEON APPROVAL. REGISTRATION HAD RMSOF 0.42. PROCEDURE WAS CONDUCTED WITHOUT ANY NAVIGATION ISSUES. THE SURGEON OFFICE REVIEWED THE ACCURACY BY MERGING THE POST OPERATIVE CT TO THE PRE OPERATIVE PLAN ON MR. 13/16 LEADS WERE OFF TRAJECTORY ACCORDING TO POST OPERATIVE CT TO PLAN MERGE. EVERY ERRANT LEAD WAS GOOD LENGTH AND FOLLOWED TRAJECTORY PATH BUT WAS TRANSLATED 2-3MM TO THE SIDE. NO COMMON PATTERN OF THESE LEADS BEING OFF IN ONE DIRECTION OR PLANE WAS FOUND. IT WAS SPORADIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605482 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS ROSA ONE 3.1 3.1.5.28

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown