BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA SURGICAL DEVICE

    MDR report key: 10612337 · Received October 1, 2020

    Report

    Report Number
    3009185973-2020-00239
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    September 14, 2020
    Report Date
    January 19, 2021
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K101791
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A DETAILED ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND LED TO THE FOLLOWING OBSERVATIONS : THE REPORTED UNEXPECTED ROBOT ARM MOVEMENT OCCURRED IN COOPERATIVE MODE, AFTER THE ARM SPEED WAS CHANGED FROM FAST TO SLOW, AND WAS DUE TO A SYNCHRONIZATION ERROR (DUE TO A KNOWN SOFTWARE ANOMALY) WHICH EVENTUALLY PROVOKED A COMMUNICATION ERROR. ALTHOUGH NO DETAILS COULD BE FOUND IN AVAILABLE DATA, IT IS SUSPECTED THAT THE REPORTED EVENT DESCRIBED AS "UNEXPECTED ARM MOVEMENT" WAS IN FACT RELATED TO A DELAY IN SENDING THE COMMAND TO REDUCE THE ARM SPEED IN COOPERATIVE MODE. MOREOVER, THE USER STILL HAD THE POSSIBILITY TO STOP THE ARM MOVEMENT BY RELEASING THE VIGILANCE DEVICE (FOOT PEDAL), AS IT WAS FULLY FUNCTIONAL. THE USER MANUAL ADEQUATELY INDICATES THAT THE VIGILANCE DEVICE MUST BE RELEASED TO AVOID ANY INCORRECT MOVEMENT OR RISK OF COLLISION AND TO CONTROL THE ARM MOVEMENTS THROUGHOUT THE PROCEDURE. CORRECTED DATA: B4: DATE OF THIS REPORT. D4: LOT NUMBER. G4: DATE RECEIVED BY MANUFACTURER. H2: IF FOLLOW-UP, WHAT TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: EVENT PROBLEM AND EVALUATION CODES. H10: ADDITIONAL NARRATIVES / DATA.

    Description of Event or Problem · 0

    THE COMPANY CLINICAL REPRESENTATIVE WAS INFORMED BY EMAIL THAT THE ROSA PUSHED ON THE PATIENT SKIN. THIS HAPPENED DURING THE REGISTRATION VALIDATION. ACCORDING TO THE DESCRIPTION OF THE SURGEON IT WAS DURING A COOPERATIVE MOVE TO CHECK THE ACCURACY OF THE FOREHEAD. THE SURGEON PLACED THE POINTER ON THE FOREHEAD AND THE ARM MOVED DOWN AND IT WAS ONLY WITH A LOT OF FORCE POSSIBLE TO GET THE ARM MOVED AWAY FROM THE PATIENT HEAD. THE REGISTRATION WAS ABORTED AND REDONE. DURING THE SECOND TIME, THE SYSTEM WAS WORKING NORMAL. THE SURGERY WAS CONTINUED. THERE WAS APPROXIMATELY 45 MINUTES DELAY, AND THE PATIENT EXHIBITED A RED PRESSURE MARK AFTER SURGERY.

    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) #: NOT APPLICABLE.

    Description of Event or Problem · 1

    THE COMPANY CLINICAL REPRESENTATIVE WAS INFORMED BY EMAIL THAT THE ROSA PUSHED ON THE PATIENT SKIN. THIS HAPPENED DURING THE REGISTRATION VALIDATION. ACCORDING TO THE DESCRIPTION OF THE SURGEON IT WAS DURING A COOPERATIVE MOVE TO CHECK THE ACCURACY OF THE FOREHEAD. THE SURGEON PLACED THE POINTER ON THE FOREHEAD AND THE ARM MOVED DOWN AND IT WAS ONLY WITH A LOT OF FORCE POSSIBLE TO GET THE ARM MOVED AWAY FROM THE PATIENT HEAD. THE REGISTRATION WAS ABORTED AND REDONE. DURING THE SECOND TIME, THE SYSTEM WAS WORKING NORMAL. THE SURGERY WAS CONTINUED. THERE WAS APPROXIMATELY 45 MINUTES DELAY, AND THE PATIENT EXHIBITED A RED PRESSURE MARK AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080319 ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA 2.5.8.4

    Patients

    Seq Age Sex Outcome Treatment
    1