BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOPIS ENT SOFTWARE WITH TGS

    MDR report key: 15927021 · Received December 6, 2022

    Report

    Report Number
    3015967359-2022-02394
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 1, 2022
    Report Date
    March 14, 2023
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    PGW
    UDI-DI
    07613327413199
    PMA / PMN Number
    K161491
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE LOG FILES WERE NOT RETURNED FOR EVALUATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED FOR THE EVENT. H3 OTHER TEXT : ONLY SESSION AND AUDIT LOGS WERE PROVIDED, NOT DEVICE FILES.

    Description of Event or Problem · 0

    PER THE CUSTOMER, THE DEVICE WAS INACCURATE BY 4MM DURING A SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 0

    PER THE CUSTOMER, THE DEVICE WAS INACCURATE BY 4MM DURING A SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362953 SCOPIS ENT SOFTWARE WITH TGS NEUROLOGICAL STEREOTAXIC INSTRUMENT PGW STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 8000-020-002 VERSION UNKNOWN 07613327413199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown