BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 8264174 · Received January 21, 2019

    Report

    Report Number
    3009185973-2019-00021
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    December 22, 2018
    Report Date
    April 8, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    NAY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. VARIOUS TESTS WERE PERFORMED FOR THE TECHNICAL INVESTIGATION. THOSE TESTS ENABLED TO CONFIRM THAT THE OPTICAL DISTANCE SENSOR WAS WITHIN SPECIFICATION. THE ISSUE WAS CAUSED BY THE ROBOT ARM THAT WAS FOUND TO BE OUT OF CALIBRATION. THE ROBOT ARM WAS RECALIBRATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OPTICAL DISTANCE SENSOR FAILED AND ACCURACY TEST PERFORMED PART OF A PREVENTIVE MAINTENANCE.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OPTICAL DISTANCE SENSOR FAILED AND ACCURACY TEST PERFORMED PART OF A PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58562 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE NAY MEDTECH SA OPTICAL DISTANCE SENSOR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1