BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS ORT400 OPERATING ROOM TABLE

    MDR report key: 12801533 · Received November 12, 2021

    Report

    Report Number
    3010326005-2021-00015
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    October 12, 2021
    Report Date
    November 11, 2021
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    KXJ
    UDI-DI
    00857534006691
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIRM IS INVESTIGATING THE OBSERVED PHASE SHIFT OR IMAGE DISTORTION AND FACTORS SUCH AS EDDY CURRENT COMPENSATION AND PROTOCOL IMAGING PARAMETERS UTILIZED, AS WELL AS POTENTIAL EDDY CURRENT INTERFERENCE FROM THE OPERATING ROOM TABLE. AT THIS TIME A DEVICE MALFUNCTION HAS NOT BEEN IDENTIFIED. A FOLLOWUP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THIS EVENT WAS TRACED TO USER ERROR OF INCORRECT LOCALIZER SETTINGS; THE FIRST LOCALIZER SETTINGS WERE NOT ZEROED OUT WHICH LED TO AN ERROR IMPACTING PATIENT REGISTRATION. THE PHASE SHIFT WAS REPORTED TO BE OBSERVED PRIOR TO ABLATION THERAPY, AFTER WHICH COORDINATE ADJUSTMENTS WERE MADE AND THE PROCEDURE CONTINUED WITHOUT FURTHER IMPACT. A DEVICE MALFUNCTION WAS NOT IDENTIFIED DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MAGNETIC RESONANCE-GUIDED LITT PROCEDURE, THE AREA INTENDED FOR ABLATION APPEARED TO BE OFF TARGET, PRIOR TO ABLATION. THE CASE WAS COMPLETED AND NO PATIENT OR PROCEDURAL IMPACT OR CONSEQUENCE WAS REPORTED. THE PLANNED THERAPY WAS DELIVERED AFTER THE NEUROSURGEON COMPENSATED FOR THE OBSERVED SHIFT IN IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705461 IMRIS ORT400 OPERATING ROOM TABLE OPERATING ROOM TABLE KXJ IMRIS - DEERFIELD IMAGING, INC. ORT 400 00857534006691

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown