BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 8188645 · Received December 21, 2018

    Report

    Report Number
    3009185973-2018-00364
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 27, 2018
    Report Date
    February 27, 2019
    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
    GM
    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. THE TECHNICAL INVESTIGATION CONFIRMED THAT TWO SYSTEM FREEZES OCCURRED, BOTH DUE TO A CRASH OF THE OPERATING SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE TWO FREEZES DURING THE SURGERY. THE FIRST ONE OCCURRED WHILE THE USER SELECTED A DIFFERENT ANGLE. THE SECOND ONE OCCURRED WHILE THE USER ACTIVATED A MICRO-MOVEMENT. AFTER EACH FREEZE THE DEVICE WAS RESTARTED.

    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 THERE WERE TWO FREEZES DURING THE SURGERY. THE FIRST ONE OCCURRED WHILE THE USER SELECTED A DIFFERENT ANGLE. THE SECOND ONE OCCURRED WHILE THE USER ACTIVATED A MICROMOVEMENT. AFTER EACH FREEZE THE DEVICE WAS RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028322 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1