BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7356963 · Received March 21, 2018

    Report

    Report Number
    3009185973-2018-00086
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    March 14, 2018
    Report Date
    September 12, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT USER COULD NOT USE DIRECT TRANSFER TO TRANSFER DICOMS FROM THE O-ARM TO THE ROSA ONE DEVICE. THE DEVICE WOULD ALSO DISPLAY AN ERROR MESSAGE. INVESTIGATION OF EVENT THROUGH DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTORY FACTORS. IT WAS HOWEVER NOTED THAT THE EVENT OCCURRED ON A RECENTLY INSTALLED WORKSTATION. INVESTIGATION OF THE CORRESPONDING DATA LOG FILES ENABLED TO CONFIRM THE DEVICE MALFUNCTION AND INDICATED THAT THE ISSUE WAS DUE TO DESIGN DEFECT AR-1742, RELATED TO SOFTWARE IQVIEW 3.0 MISCONFIGURATION. THE DEVICE ROSA ONE BS17008 IS NOT FDA APPROVED, BUT IT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW - K151359. UDI-(B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT USER COULD NOT USE DIRECT TRANSFER TO TRANSFER DICOMS FROM THE O-ARM TO THE ROSA ONE DEVICE. THE DEVICE WOULD ALSO DISPLAY AN ERROR MESSAGE. INVESTIGATION OF EVENT THROUGH DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTORY FACTORS. IT WAS HOWEVER NOTED THAT THE EVENT OCCURRED ON A RECENTLY INSTALLED WORKSTATION. INVESTIGATION OF THE CORRESPONDING DATA LOG FILES ENABLED TO CONFIRM THE DEVICE MALFUNCTION AND INDICATED THAT THE ISSUE WAS DUE TO A DESIGN DEFECT. A NON-CONFORMITY WAS RAISED INTERNALLY REGARDING THE SUBJECT PRODUCT ISSUE, A MISCONFIGURATION OF IQ-VIEW PREVENTS ROSA FROM READING IMPORTED IMAGES, ON BOTH BRAIN & SPINE APPLICATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE ROSA ONE (B)(4) IS NOT FDA APPROVED, BUT IT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED (B)(4). THE DEVICE (B)(4) 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

    IT WAS REPORTED THAT THE SURGEON HAD SOME DIFFICULTIES TO TRANSFER IMAGES TO THE DEVICE COMPUTER DIRECTLY FROM THE O-ARM AND HE NEEDED TO TRANSFER IMAGES THROUGH USB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203393 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE SOFTWARE 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1