BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICAL DISTANCE SENSOR

    MDR report key: 16417899 · Received February 22, 2023

    Report

    Report Number
    3009185973-2023-00002
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    February 2, 2023
    Report Date
    July 31, 2023
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244032195
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: INVESTIGATION FOUND TO BE INCORRECT MEASUREMENT. THEREFORE, THIS IS NO LONGER A REPORTABLE EVENT. THE REPORTED OPTICAL DISTANCE SENSOR (ODS) ACCURACY AND APPLICATIVE TESTS WERE CONFIRMED TO HAVE FAILED DURING THE PREVENTIVE MAINTENANCE (PM) APPROXIMATELY 5 MONTHS AGO. DESPITE HAVING ISSUES WITH THE ODS TESTS, THE FIELD SERVICE ENGINEER (FSE) WAS ABLE TO CONFIRM THE FUNCTIONALITY OF THE ROSA SYSTEM AS THE ROBOT CORRECTLY PASSED BOTH THE ACCURACY AND APPLICATIVE TESTS USING MARKER REGISTRATION WITH THE POINTER PROBE. THE SYSTEM STILL MET ALL FUNCTIONAL REQUIREMENTS WHEN IT WAS RELEASED BACK TO THE CUSTOMER. THE ASSOCIATED SYSTEM LOG FILES WERE PROVIDED AND REVIEWED BY A SUBJECT MATTER EXPERT. THE LOGS CONFIRM THAT ALL FIVE ODS ACCURACY TEST ATTEMPTS WERE REJECTED AS THE VERIFICATION VALUES WERE ABOVE THE SYSTEM¿S DISTANCE THRESHOLD. AMONG THESE FAILED ATTEMPTS, MULTIPLE DISTANCE SENSOR DISCONNECTION ERRORS WERE OBSERVED. ALTHOUGH IT IS POSSIBLE THAT THESE DISCONNECTION ERRORS CONTRIBUTED TO THE ACCURACY ISSUES, IT CANNOT BE DEFINITIVELY CONFIRMED. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AS THE POINTER PROBE TESTS PASSED DURING PM, THE REPORTED ODS INACCURACY IS MOST LIKELY NOT COMING FROM THE ROBOT ITSELF BUT RATHER A HARDWARE RELATED MALFUNCTION WITH THE ODS. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT 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 THAT WHILE PERFORMING PREVENTATIVE MAINTENANCE ON THE ROSA ROBOT, THE OPTICAL DISTANCE SENSOR FAILED THE ROSA BRAIN ACCURACY TEST AND CONTACTLESS REGISTRATION APPLICATIVE TEST. CONTACTLESS REGISTRATION WAS THEN PERFORMED ON THE PHANTOM TEST HEAD. REGISTRATION WAS COMPLETED WITH NO ERRORS. HOWEVER, THE APPLICATIVE TEST FAILED AS THE ROBOTIC ARM WAS INACCURATE FOR 5 OUT OF THE 9 TRAJECTORIES AND MISSED THE INTENDED TARGET. THE ROBOT CORRECTLY PASSED BOTH THE ACCURACY TEST AND THE APPLICATIVE TEST USING MARKER REGISTRATION WITH THE POINTER PROBE. 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
    1571941 OPTICAL DISTANCE SENSOR MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM HAW MEDTECH SAS N/A N/A 03760244032195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown