BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 8239270 · Received January 11, 2019

    Report

    Report Number
    3009185973-2019-00009
    Event Type
    Injury
    Date Received
    January 11, 2019
    Date of Event
    December 13, 2018
    Report Date
    April 1, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    N/A
    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

    IT WAS REPORTED THAT THE COMPUTER WAS NOT ABLE TO CONNECT TO THE CONTROLLER. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ANALYSIS OF DATA LOG CONFIRMED THE CONNECTION WAS IMPOSSIBLE. BASED ON THE COMPLAINT DESCRIPTION SEVERAL CONNECTIONS TO ROBOT ARM FAILED PROBABLY DUE TO THE BAD CONNECTION OR DISCONNECTION OF THE STARC CARD FOLLOWING THE ROBOT TRANSPORTATION BETWEEN THE STORAGE AND OPERATING ROOM. THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K172444. (B)(4). PATIENT CODE(S) : 3191 - NO CODE AVAILABLE : THE SURGERY WAS CANCELLED.

    Description of Event or Problem · 0

    ON (B)(6). 2018 THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE (APHM MARSEILLE) TO ASSIST A SURGERY CASE. WHEN THE SURGEON WANTED TO START MARKER REGISTRATION A MESSAGE APPEARED ON THE SCREEN "IMPOSSIBLE TO CONNECT TO THE ROBOT, THE DEVICE WILL SHUT DOWN". THE FSE DECIDED TO RESTART THE DEVICE AND AT THE SAME STEP, THE SAME MESSAGE APPEARED. THE FSE RESTART THE DEVICE AGAIN AND LOGGED INTO TECHNICAL SESSION. THE LOG FILES READING SHOWED THAT IT WAS IMPOSSIBLE FOR THE COMPUTER TO CONNECT TO THE CONTROLLER. THE FSE DECIDED TO REMOVE THE ROBOT FROM THE OPERATING ROOM AND REMOVE ALL COVER PANEL TO ACCESS TO THE CONTROLLER. BEFORE A TOO BIG LOST TIME, THE FSE DECIDED WITH THE SURGEON TO CANCEL THE SURGERY CASE WITH THE DEVICE. AFTER A COMPLETE CHECKING THE CONNECTION BETWEEN ROBOT ARM-CONTROLLER-COMPUTER SEEMS TO WORK WELL. THE FSE SUSPECTS THAT THE STARC CARD WAS UNPLUGGED (CONTROLLER LOG FILE WILL CONFIRM IT). A POSSIBLE EXPLANATION OF THIS HYPOTHESIS IS THAT THE FLOOR IS NOT PERFECTLY FLAT BETWEEN THE STORAGE SPACE AND THE OR. AFTER SEVERAL TEST, THE ROBOT WORKED WELL ON BOTH TECHNICAL AND MAINTENANCE SESSION.

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K172444. 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) 2018 THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ((B)(6)) TO ASSIST A SURGERY CASE. WHEN THE SURGEON WANTED TO START MARKER REGISTRATION A MESSAGE APPEARED ON THE SCREEN "IMPOSSIBLE TO CONNECT TO THE ROBOT, THE DEVICE WILL SHUT DOWN". THE FSE DECIDED TO RESTART THE DEVICE AND AT THE SAME STEP, THE SAME MESSAGE APPEARED. THE FSE RESTART THE DEVICE AGAIN AND LOGGED INTO TECHNICAL SESSION. THE LOG FILES READING SHOWED THAT IT WAS IMPOSSIBLE FOR THE COMPUTER TO CONNECT TO THE CONTROLLER. THE FSE DECIDED TO REMOVE THE ROBOT FROM THE OPERATING ROOM AND REMOVE ALL COVER PANEL TO ACCESS TO THE CONTROLLER. BEFORE A TOO BIG LOST TIME, THE FSE DECIDED WITH THE SURGEON TO CANCEL THE SURGERY CASE WITH THE DEVICE. AFTER A COMPLETE CHECKING THE CONNECTION BETWEEN ROBOT ARM-CONTROLLER-COMPUTER SEEMS TO WORK WELL. THE FSE SUSPECTS THAT THE STARC CARD WAS UNPLUGGED (CONTROLLER LOG FILE WILL CONFIRM IT). A POSSIBLE EXPLANATION OF THIS HYPOTHESIS IS THAT THE FLOOR IS NOT PERFECTLY FLAT BETWEEN THE STORAGE SPACE AND THE OPERATING ROOM. AFTER SEVERAL TEST, THE ROBOT WORKED WELL ON BOTH TECHNICAL AND MAINTENANCE SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31987 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1 Other