BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 12745650 · Received November 3, 2021

    Report

    Report Number
    3009185973-2021-00180
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 4, 2021
    Report Date
    May 24, 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
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT THE REVIEW OF DATA DID NOT PERMIT TO CONFIRM THE EVENT OR A RELIABLE ROOT CAUSE FOR THE ISSUE. HOWEVER, THE FSE TEAM INFORMATION PERMITTED TO DETERMINED THAT AN INTERVENTION OF STAÜBLI WAS ORDERED TO TIGHTENED THE DEVICE BREAKS WHICH PERMITTED TO REDUCE THE ERROR OBSERVED - ONLY VISIBLE IF A FORCE IS APPLIED ON THE ARM. IT IS NOTED FORCES APPLIED ON THE ARM DURING OPERATION IS NOT RECOMMENDED ACCORDING TO THE IFU. THE ANALYSIS ALSO SHOWS THAT THE MARKER REGISTRATION VERIFICATION WAS INCORRECTLY PERFORMED WHICH DID NOT PERMIT TO CONFIRM THE REGISTRATION ACCURACY. THE DHR REVIEW PERMITTED TO CONFIRM THAT THE DEVICE PASSED TWO CYCLES OF PREVENTIVE MAINTENANCE SHOWING THAT THE DEVICE IS COMPLIANT TO ITS SPECIFICATIONS. THE EVENT DESCRIBED IN THE COMPLAINT IS CONFIRMED BY FSE TEAM INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CASE AT OCHSNER MEDICAL CENTER, AN ISSUED OCCURRED WITH THE FIXATION OF THE ARM IN AXIAL POSITION. WHILE PERFORMING A VISUALASE CASE, THE SURGEON WAS POSITIONED ON TRAJECTORY 1 IN AXIAL POSITION. THE SURGEON DRILLED, AND THEN INSERTED THE PMT VISUALASE BOLT INTO SAID TRAJECTORY. HE THEN EXCHANGED ADAPTERS TO THE ROSA 3.2 METAL DRILL BIT TO TAKE THE MEASUREMENT FOR THE LASER FIBER. ONCE THIS WAS DONE, THE SURGEON RECOGNIZED THAT THE TRAJECTORY WAS SLIGHTLY BELOW THE IMPLANTED BOLT. FOLLOWING THIS, THE SURGEON WAS ABLE TO PHYSICALLY PUSH THE ROBOT ARM UPWARDS (SPECIFICALLY, OUT OF AXIAL POSITION) AT MINIMUM 4/5MM. THIS WAS WHILE THE ROBOT ARM WAS LOCKED IN AXIAL POSITION ALONG THE TARGET. THE SURGEON IMMEDIATELY RECOGNIZED THAT THE ARM WAS NOT LOCKED IN AXIAL. A CONFIRMATION SPIN WAS COMPLETED, AND THE TRAJECTORY WAS ONLY 2MM OFF TARGET SO THE CASE WAS COMPLETED.

    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. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE AT OCHSNER MEDICAL CENTER, AN ISSUED OCCURRED WITH THE FIXATION OF THE ARM IN AXIAL POSITION. WHILE PERFORMING A VISUALASE CASE, WE WERE POSITIONED ON TRAJECTORY 1 IN AXIAL POSITION. THE SURGEON DRILLED, AND THEN INSERTED THE PMT VISUALASE BOLT INTO SAID TRAJECTORY. WE THEN EXCHANGED ADAPTERS TO THE ROSA 3.2 METAL DRILL BIT TO TAKE THE MEASUREMENT FOR THE LASER FIBER. ONCE THIS WAS DONE, THE SURGEON RECOGNIZED THAT THE TRAJECTORY WAS SLIGHTLY BELOW THE IMPLANTED BOLT. FOLLOWING THIS, THE SURGEON WAS ABLE TO PHYSICALLY PUSH THE ROBOT ARM UPWARDS (SPECIFICALLY, OUT OF AXIAL POSITION) AT MINIMUM 4/5MM. THIS WAS WHILE THE ROBOT ARM WAS LOCKED IN AXIAL POSITION ALONG THE TARGET. THE SURGEON IMMEDIATELY RECOGNIZED THAT THE ARM WAS NOT LOCKED IN AXIAL. A CONFIRMATION SPIN WAS COMPLETED, AND THE TRAJECTORY WAS ONLY 2MM OFF TARGET SO THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643519 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