BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 8072899 · Received November 15, 2018

    Report

    Report Number
    3009185973-2018-00303
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    July 5, 2018
    Report Date
    December 18, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    OLO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THERE WERE FOUR 3D-REGISTRATION FAILURES. THE RECHNICAL INVESTIGATION CONFIRMED THAT THE 3D-REGISTRATION FAILED TWO CONSECUTIVE TIMES DUE TO THE DISTURBANCE OF THE OPTICAL PATIENT REFERENCE BY THE 3D X-RAY PATTERN FRAME, REFERENCED AS DESIGN DEFECT REFERENCE AR-1715. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THREE PREVIOUS COMPLAINTS WERE RECEIVED FOR THIS DEVICE DUE TO THE SAME ROOT CAUSE. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY TWO 3D-REGISTRATION FAILURES OCCURRED. THE REGISTRATION STEPS WERE REPEATED UNTIL THE ISSUE WAS RESOLVED. SURGERY WAS COMPLETED SUCCESSFULLY.

    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. THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN, CLASSIFIED HAW AND CLEARED UNDER K172444.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY TWO 3D-REGISTRATION FAILURES OCCURRED. THE REGISTRATION STEPS WERE REPEATED UNTIL THE ISSUE WAS RESOLVED. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915460 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE OLO MEDTECH SA ROSA ONE 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1