BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA BRAIN

    MDR report key: 7746947 · Received August 3, 2018

    Report

    Report Number
    3009185973-2018-00215
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    July 5, 2018
    Report Date
    January 30, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PK151359
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE TECHNICAL INVESTIGATION INDICATED THAT AN ISSUE, NOT MENTIONED IN THE COMPLAINT DESCRIPTION, OCCURRED DURING THE 3D RECONSTRUCTION OF A CT AND A MRI, DUE TO AN UNKNOWN CAUSE. THE CAUSES OF THE DIFFICULTY TO MOVE THE ARM IN COOPERATIVE MODE AND OF THE UNEXPECTED ROBOT ARM MOVEMENT CAN NOT BE DETERMINED. THOSE THREE REPORTED ISSUES CAN NOT BE INVESTIGATED FURTHER AS SOME ELEMENTS OF THE PATIENT FOLDER ARE NOT AVAILABLE FOR INVESTIGATION, BUT ARE CONFIRMED AS A COMPANY REPRESENTATIVE WAS PRESENT.

    Description of Event or Problem · 0

    ROBOT ARM HAD NAVIGATED TO TRAJECTORY. SURGEON CONFIRMED BOLT PLACEMENT FROM PREVIOUS SURGERY, AND ATTEMPTED TO CLEAR ROBOT ARM TO SEND IT TO NEXT TRAJECTORY. ROBOT ARM WOULD NOT MOVE AWAY ENOUGH IN "FREE/FAST" COOPERATIVE MOVEMENT. FIELD SERVICE ENGINEER ATTEMPTED TO HAVE SURGEON CLEAR ROBOT ARM WHILE IN AXIAL COOPERATIVE MOTION, AND WAS UNSUCCESSFUL. FSE INSTRUCTED SURGEON TO ADJUST GRIP ON ROBOT ARM, AND HAND PLACEMENT. ROBOT ARM WAS ABLE TO BE MOVED SLIGHTLY IN COOPERATIVE MODE. SURGEON ASKED FOR ARM TO BE PUT INTO "FREE/FAST" AND ARM APPEARED TO DROP DOWN TOWARDS PATIENT. NO PATIENT INVOLVEMENT DIRECTLY AS SURGEON RELEASED VIGILANCE DEVICE TO PREVENT COLLISION. SLIGHT DELAY OF LESS THAN 5 MINUTES TO ADEQUATELY CLEAR ARM FROM POSITION AND SEND TO NEXT TRAJECTORY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ROBOT ARM HAD NAVIGATED TO TRAJECTORY. SURGEON CONFIRMED BOLT PLACEMENT FROM PREVIOUS SURGERY, AND ATTEMPTED TO CLEAR ROBOT ARM TO SEND IT TO NEXT TRAJECTORY. ROBOT ARM WOULD NOT MOVE AWAY ENOUGH IN "FREE/FAST" COOPERATIVE MOVEMENT. FIELD SERVICE ENGINEER ATTEMPTED TO HAVE SURGEON CLEAR ROBOT ARM WHILE IN AXIAL COOPERATIVE MOTION, AND WAS UNSUCCESSFUL. FSE INSTRUCTED SURGEON TO ADJUST GRIP ON ROBOT ARM, AND HAND PLACEMENT. ROBOT ARM WAS ABLE TO BE MOVED SLIGHTLY IN COOPERATIVE MODE. SURGEON ASKED FOR ARM TO BE PUT INTO "FREE/FAST" AND ARM APPEARED TO DROP DOWN TOWARDS PATIENT. NO PATIENT INVOLVEMENT DIRECTLY AS SURGEON RELEASED VIGILANCE DEVICE TO PREVENT COLLISION. SLIGHT DELAY OF LESS THAN 5 MINUTES TO ADEQUATELY CLEAR ARM FROM POSITION AND SEND TO NEXT TRAJECTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589582 ROSA BRAIN COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA BRAIN 3.0.0.21

    Patients

    Seq Age Sex Outcome Treatment
    1