BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA SURGICAL DEVICE

    MDR report key: 6476333 · Received April 10, 2017

    Report

    Report Number
    3009185973-2017-00330
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    November 23, 2016
    Report Date
    April 10, 2017
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K101791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PW, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE RO 15 044 HAS BEEN INSPECTED FOR INVESTIGATION PURPOSE. THE ANALYSIS PERFORMED CONFIRMED THAT PC CONFIGURATION ISSUE CAUSED THE OBSERVED ISSUE. THE INTERNAL COMPLAINT REFERENCE IS THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    DURING AN INTERVENTION PERFORMED BY OUF FIELD ENGINEER, IT WAS IDENTIFIED THAT A SOFTWARE FAILURE HAS BEEN DETECTED. SYSTEM SHUTDOWN AND THEN HAS BEEN RESTARTED. ERROR OCCURS IN BOTH ROSA USER PROFILE AND MAINTENANCE PROFILE. IT WAS ALSO REPORTED THAT THE ROSANNA SOFTWARE COULD NOT BE OPENED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257118 ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA 2.5.8

    Patients

    Seq Age Sex Outcome Treatment
    1