BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 10579884 · Received September 24, 2020

    Report

    Report Number
    3009185973-2020-00217
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 28, 2020
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THERE WAS A WIRING PROBLEM WITH THE DISTANCE SENSOR. IT CAUSED THE DISTANCE SENSOR TO REPEATEDLY DISCONNECT. THIS IS WHY IT FAILED THE TEST FOUR TIMES BEFORE BEING ABLE TO PASS. IN ORDER TO SOLVE THIS PROBLEM, IT IS RECOMMENDED TO UNPLUG THE CABLE FROM THE DISTANCE SENSOR AND FROM THE COMPUTER, AND PLUG IT BACK IN AGAIN.

    Description of Event or Problem · 0

    AFTER TRYING 5 TIMES, THE DISTANCE SENSOR PASSED THE TEST. THE FIRST 3 TIMES THAT THE FIELD SERVICE ENGINEER (FSE) TESTED, THE LASER STOPPED AT A TRAJECTORY BEFORE 100/168 AND GAVE THE ERROR "UNABLE TO COMPUTE PROJECTED TOOL POSITION". THE FSE SHUT DOWN THE ROBOT AND UNPLUGGED FOR 15 MINUTES. THE 4TH TIME, THE FSE TRIED HE HAD SOME TROUBLE CALIBRATING THE LASER. AFTER TRYING THIS A FEW TIMES, THE FSE WAS ABLE TO GET THE CALIBRATION ACCEPTED. THE FSE MOVE THE POOL BALL SLIGHTLY TO SEE IF IT WAS THE ANGLE THAT THE ARM WAS APPROACHING THE BALL. THIS TIME THE ARM STOPPED AT 152/168. THE ERROR MESSAGE WAS "MOVE TO POSITION FAILURE: DO YOU WANT TO TRY AGAIN?". THE FSE CLICKED YES AND THE ERROR "UNABLE TO COMPUTE PROJECTED TOOL POSITION" WINDOW WAS BEHIND THE INITIAL ERROR. THE FSE BROUGHT THE LASER BACK TO HOME AND ADJUSTED THE POOL BALL A 3RD TIME AIMING TO BE IN THE GREEN BETWEEN TO TWO PREVIOUS POSITIONS. THE 5TH TIME THE LASER PASSED THE TEST.

    Additional Manufacturer Narrative · 1

    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 · 1

    AFTER TRYING 5 TIMES, THE DISTANCE SENSOR PASSED THE TEST. THE FIRST 3 TIMES THAT THE FIELD SERVICE ENGINEER (FSE) TESTED, THE LASER STOPPED AT A TRAJECTORY BEFORE 100/168 AND GAVE THE ERROR "UNABLE TO COMPUTE PROJECTED TOOL POSITION". THE FSE SHUT DOWN THE ROBOT AND UNPLUGGED FOR 15 MINUTES. THE 4TH TIME, THE FSE TRIED HE HAD SOME TROUBLE CALIBRATING THE LASER. AFTER TRYING THIS A FEW TIMES, THE FSE WAS ABLE TO GET THE CALIBRATION ACCEPTED. THE FSE MOVE THE POOL BALL SLIGHTLY TO SEE IF IT WAS THE ANGLE THAT THE ARM WAS APPROACHING THE BALL. THIS TIME THE ARM STOPPED AT 152/168. THE ERROR MESSAGE WAS "MOVE TO POSITION FAILURE: DO YOU WANT TO TRY AGAIN?". THE FSE CLICKED YES AND THE ERROR "UNABLE TO COMPUTE PROJECTED TOOL POSITION" WINDOW WAS BEHIND THE INITIAL ERROR. THE FSE BROUGHT THE LASER BACK TO HOME AND ADJUSTED THE POOL BALL A 3RD TIME AIMING TO BE IN THE GREEN BETWEEN TO TWO PREVIOUS POSITIONS. THE 5TH TIME THE LASER PASSED THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045162 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA OPTICAL DISTANCE SENSOR ROSA3-277B

    Patients

    Seq Age Sex Outcome Treatment
    1