BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 8073064 · Received November 15, 2018

    Report

    Report Number
    3009185973-2018-00306
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    February 8, 2018
    Report Date
    November 16, 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

    EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. TECHNICAL INVESTIGATION CONFIRMED THAT THE USER TRIED SIX TIMES TO PERFORM A 3D-REGISTRATION, BUT THE FIVE FIRST ATTEMPTS FAILED. AT THE SIXTH ATTEMPT THE BOUNDING BOX WAS REDEFINED PROPERLY BY THE USER WHICH ENABLED A CORRECT DETECTION OF MARKERS AND THE CALCULATION WAS SUCCESSFUL. THE DEVICE WORKED AS INTENDED, THE EVENT IS DUE TO USER ERROR IN THE DEFINITION OF THE BOUNDING BOX. THE SURGEON IS TRAINED TO THE USE OF THE ROSA ONE DEVICE AND IS CONSIDERED AS EXPERIENCED.

    Description of Event or Problem · 0

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

    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 THERE WERE 3D-REGISTRATION FAILURES DURING A SURGERY. THE REGISTRATION STEPS WERE REPEATED UNTIL ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915261 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE OLO MEDTECH SA ROSA ONE 3.1.0.2

    Patients

    Seq Age Sex Outcome Treatment
    1