BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE BRAIN

    MDR report key: 16452024 · Received February 28, 2023

    Report

    Report Number
    3009185973-2023-00003
    Event Type
    Injury
    Date Received
    February 28, 2023
    Report Date
    May 17, 2023
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244034793
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; H2; H3; H6. CORRECTED: B1. THE ASSOCIATED SYSTEM LOG FILES WERE PROVIDED AND REVIEWED BY A SUBJECT MATTER EXPERT. A FULL ANALYSIS OF THE DATA LOGS CONFIRMED THE REPORTED EVENT AND PERMITTED TO CONCLUDE THAT THE EVENT WAS DUE TO A DIFFERENCE BETWEEN THE MARKERS DEFINED IN THE IMAGE AND THE MARKERS RECORDED WITH THE ROBOT. THE FOLLOWING FACTS WERE IDENTIFIED FROM THE LOGS: - AMONG THE 7 BONE FIDUCIALS POSITIONED ON PATIENT¿S HEAD, THE 7TH FIDUCIAL WAS NOT USED DURING PLANNING AS A MARKER. - WHEN REGISTERING THE POINTS WITH THE ROBOT, THE 6TH FIDUCIAL WAS IGNORED BUT THE 7TH FIDUCIAL WAS RECORDED INSTEAD. - AS THE 7TH FIDUCIAL DIDN¿T EXIST IN THE PLANNING AND THE 6TH DIDN¿T EXIST IN THE POINT TAKEN BY THE ROBOT, ROSANNA COULD NOT FIND ANY GOOD MATCH AND RETURNED THAT THE REGISTRATION WAS IMPOSSIBLE. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY RECORDS WERE NOT REVIEWED AS ROOT CAUSE IS ATTRIBUTED TO USE ERROR. BASED ON THE INVESTIGATION, THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A USER ERROR IN THE REGISTRATION WORKFLOW. INSTRUCTIONS FOR SELECTION AND POSITIONING OF THE APPROPRIATE FIDUCIALS ARE PROVIDED IN SECTION 2.4.1.2 THE ROSA ONE BRAIN APPLICATION USER MANUAL. SECTION 4.6.1 INDICATES THAT THE PATIENT REGISTRATION PROCESS MATCHES THE PHYSICAL POSITION OF THE PATIENT WITH THE POSITION OF THE LOADED PATIENT EXAM. AS SUCH, THE USER CREATED A DISCREPANCY BETWEEN THE TWO BY SELECTING MISMATCHING REGISTRATION MARKERS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). ROBOT REMAINS AT HOSPITAL AND IS ANTICIPATED TO BE EVALUATED. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING SURGERY, THAT DURING THE REGISTRATION PORTION OF AN SEEG PROCEDURE, THE ROBOT WAS UNABLE TO COMPUTE THE REGISTRATION. THERE WERE MULTIPLE ATTEMPT AND MARKERS WERE PLACED SLIGHTLY DIFFERENT, ROTATED THE POSITION ON THE HEAD DIFFERENTLY, AND TRIED TO REGISTER WITH A DIFFERENT NUMBER OF MARKERS. A CT SCAN FROM AN O-ARM WAS INITIALLY USED TO IDENTIFY THE FIDUCIALS FOR MARKER REGISTRATION. AFTER THE 3RD OR 4TH ATTEMPT, A SECOND O-ARM SPIN WAS OBTAINED TO SEE IF A NEW SCAN WOULD MAKE A DIFFERENCE. FIDUCIALS WERE CHECKED WERE SECURELY IN THE SKULL AND NOT MOVING; THEY WERE AND COULD EVEN SEE ON THE O-ARM SCAN THAT THE BONE FIDUCIALS HAD GOOD PURCHASE. A FEW RESTARTS WERE ATTEMPTED OF THE ROBOT AND EVEN THAT DID NOT FIX THE ISSUE OF THE ROBOT NOT BEING ABLE TO COMPUTED. THERE WAS LAST ATTEMPT AT REGISTERING BEFORE THE SURGEON ABORTED THE SURGERY BECAUSE OF THIS ISSUE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753386 ROSA ONE BRAIN COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS N/A N/A 03760244034793

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization