BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA SURGICAL DEVICE

    MDR report key: 7233560 · Received February 1, 2018

    Report

    Report Number
    3009185973-2018-00043
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Date of Event
    May 26, 2017
    Report Date
    February 1, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PK101791
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION PERFORMED ON THE DATA LOGS POINTED PUT THAT THE ROOT CAUSE OF THE COMMUNICATION ERROR IS A RESIDUAL SOFTWARE BUG ALREADY KNOW. AN ISSUE EVALUATION HAS BEEN OPEN TO TACKLE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY WHILE THE ROBOT ARM WAS MOVING TO A TRAJECTORY A COMMUNICATION ERROR OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78301 ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA 2.5.8 2.5.8.4

    Patients

    Seq Age Sex Outcome Treatment
    1