BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOPIS ENT SOFTWARE WITH TGS

    MDR report key: 16961302 · Received May 19, 2023

    Report

    Report Number
    3015967359-2023-01130
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 20, 2023
    Report Date
    July 25, 2023
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    HAW
    UDI-DI
    07613327413199
    PMA / PMN Number
    K161491
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. LOG FILES NOT SUBMITTED BY CUSTOMER FOR EVALUATION.

    Description of Event or Problem · 0

    PER THE CUSTOMER THERE WERE MAJOR ACCURACY ISSUES WITH THEIR SCOPIS SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    PER THE CUSTOMER THERE WERE MAJOR ACCURACY ISSUES WITH THEIR SCOPIS SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873485 SCOPIS ENT SOFTWARE WITH TGS NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 8000-020-002 VERSION UNKNOWN 07613327413199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown