BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 9150501 · Received October 3, 2019

    Report

    Report Number
    3009185973-2019-00343
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 6, 2019
    Report Date
    March 30, 2020
    Manufacturer
    MEDTECH SA
    Product Code
    OLO
    PMA / PMN Number
    K182848
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. IN THE FIRST MDR SUBMISSION FOR THIS EVENT IT HAS BEEN INDICATED THAT THE SURGERY WAS CONVERTED TO A TRADITIONAL SURGERY, WITHOUT THE USE OF THE ROSA ONE DEVICE. HOWEVER FURTHER INFORMATION HAVE BEEN RECEIVED SINCE, INDICATING THAT A DIFFERENT ROSA ONE DEVICE HAS BEEN USED TO COMPLETE THE SURGERY.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW WERE NOT PERFORMED BASED ON THE LOW SEVERITY OF THIS COMPLAINT. THE TECHNICAL INVESTIGATION CONCLUDED THAT THE DEVICE WAS UNABLE BOOT PROPERLY BECAUSE THE BOOT SEQUENCE IN THE BIOS WAS INCORRECTLY SET SO, THE COMPUTER ATTEMPTED TO BOOT ON THE SURGEON USB KEY FIRST. THE CAUSE FOR THE INCORRECT BOOT SEQUENCE REMAINS UNKNOWN. THE BOOT SEQUENCE WAS MODIFIED REGARDING THE CORRECT WORK INSTRUCTION AND THE ISSUE WAS SOLVED.

    Description of Event or Problem · 0

    ON 6-SEP-2019, A COMPANY FIELD SERVICE ENGINEER (FSE) WAS TOLD BY A NURSE THAT THE DEVICE WAS NOT BOOTING. AFTER CHECKING THE ROBOT, THE MESSAGE "INVALID SYSTEM DISK" WAS PRINTED ON THE CAMERA STAND SCREEN. THE FSE, AFTER CHECKING THE BOOTING ORDER AND REMOVING ALL THE USB KEYS FROM THE SYSTEM, SUCCEED TO START CORRECTLY THE ROBOT.

    Description of Event or Problem · 0

    ON 6-SEP-2019, A COMPANY FIELD SERVICE ENGINEER (FSE) WAS TOLD BY A NURSE THAT THE DEVICE WAS NOT BOOTING. AFTER CHECKING THE ROBOT, THE MESSAGE "INVALID SYSTEM DISK" WAS PRINTED ON THE CAMERA STAND SCREEN. THE FSE, AFTER CHECKING THE BOOTING ORDER AND REMOVING ALL THE USB KEYS FROM THE SYSTEM, SUCCEED TO START CORRECTLY THE ROBOT.

    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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019, A COMPANY FIELD SERVICE ENGINEER (FSE) WAS TOLD BY A NURSE THAT THE DEVICE WAS NOT BOOTING. AFTER CHECKING THE ROBOT, THE MESSAGE "INVALID SYSTEM DISK" WAS PRINTED ON THE CAMERA STAND SCREEN. THE FSE, AFTER CHECKING THE BOOTING ORDER AND REMOVING ALL THE USB KEYS FROM THE SYSTEM, SUCCEED TO START CORRECTLY THE ROBOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945716 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE OLO MEDTECH SA ROSA ONE 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1 Other