BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIUS GPS

    MDR report key: 21241539 · Received January 27, 2025

    Report

    Report Number
    3004142400-2024-00433
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    April 18, 2023
    Report Date
    January 27, 2025
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OLO
    UDI-DI
    00889095481297
    PMA / PMN Number
    K171651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS BEING REPORTED FOR A PROBLEM FOUND EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE QUALITY OF THE DIGITALLY RECONSTRUCTED RADIOGRAPH (DRR) IS DIRECTLY CORRELATED WITH THE QUALITY AND PROTOCOL OF THE PREOPERATIVE SCAN. INVESTIGATION OF THE CASE LOGS AND PREOPERATIVE SCAN REVEALED THAT THE DRR APPEARS WASHED OUT AND CONTAINS HARD EDGES IN THE AP AND LATERAL VIEWS DUE TO THE PREOPERATIVE SCAN BEING OF POOR QUALITY AND APPEARING GRAINY. FURTHERMORE, THE PREOPERATIVE MERGE CONTAINED A SIGNIFICANT SHIFT. THIS MEANS THAT THE ANATOMY IN THE FLUOROSCOPIC IMAGES WAS NOT ALIGNED WITH THE ANATOMY IN THE DRR, MAKING IT MORE DIFFICULT TO VISUALIZE THE PATIENT ANATOMY WHEN CHECKING THE PREOPERATIVE MERGE. THE USER CAN ADJUST THE BRIGHTNESS AND CONTRAST OF THE DRR TO BETTER VISUALIZE PATIENT ANATOMY. ULTIMATELY, THE ISSUE WAS UNABLE TO BE RESOLVED, AND THE CASE WAS ABORTED. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND THERE IS NO FURTHER INVESTIGATION REQUIRED.

    Description of Event or Problem · 0

    TODAY DR. (B)(6) WANTED TO DO ANOTHER CASE WITH THE EGPS. BECAUSE THE PLANNED CASES CANNOT BE TRANSFERRED TO THE ROBOT FROM THE LAPTOP (SEE THE LAST EEF´S) HE TOOK THE CT SCAN VROM THE PAX SYSTEM OF THE HOSPITAL. HE PLANNED THE CASE ON THE EGPS AND WANTED TO REGISTER THE PATIENT IN THE PRE-OP CT MODUS. WHEN HE TOOK THE FLUORO SHOTS TO MERGE HE COULD ONLY SEE THE LEVELS L1 TO L3 IN A CT FLIP. THE THORACIC CT SCAN WAS TOTALLY LOST, SEE ATTACHED SCREEN SHOTS. HE HAD TO ABOARD THE CASE AND THE PATIENT HAD ANESTHESIA WITHOUT A REASON, IN GERMANY THAT IS ASSAULT IF BROUGHT TO COURT, SO NOT FUN. DR. (B)(6) WILL NOT DO ANY MORE CASES UNTIL THIS PROBLEM IS SOLVED. THREE CASES FOR THIS WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771849 EXCELSIUS GPS SYSTEM, EXCELSIUS GPS, 120V OLO GLOBUS MEDICAL, INC. 6143.1001 GPS-0278 00889095481297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other