BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7746705 · Received August 3, 2018

    Report

    Report Number
    3009185973-2018-00196
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    June 15, 2018
    Report Date
    December 6, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    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 USER FACED ISSUES WITH THE FRAME DETECTION ON THE IMAGES. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. TECHNICAL INVESTIGATION CONFIRMED THE EVENT: THE LEKSELL FRAME HEAD FIXATION SCREWS WERE DETECTED AS MARKERS BY THE DEVICE. THIS EVENT IS DUE TO A KNOWN DESIGN DEFECT.

    Description of Event or Problem · 0

    SURGEON FACED ISSUES WITH THE FRAME DETECTION ON THE IMAGES HE ACQUIRED WITH THE O-ARM 2 DURING A SURGERY. SURGEON HAD TO SWITCH TO ANOTHER REGISTRATION METHOD - BONE FIDUCIALS. THIS EVENT CAUSED A DELAY LESS THAN 30 MINUTES TO THE SURGERY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4). THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K151359/K172444.

    Description of Event or Problem · 1

    SURGEON FACED ISSUES WITH THE FRAME DETECTION ON THE IMAGES HE ACQUIRED WITH THE O-ARM 2 DURING A SURGERY. SURGEON HAD TO SWITCH TO ANOTHER REGISTRATION METHOD - BONE FIDUCIALS. THIS EVENT CAUSED A DELAY LESS THAN 30 MINUTES TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588928 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE SOFTWARE 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1