BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOPIS ENT SOFTWARE WITH TGS

    MDR report key: 14878869 · Received June 30, 2022

    Report

    Report Number
    3015967359-2022-01245
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 22, 2022
    Report Date
    August 12, 2022
    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
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 0

    PER THE CUSTOMER, THERE WAS AN ISSUE WITH THE SYSTEM LOADING IMAGES. THE LOADING WAS DELAYED BY SEVERAL MINUTES AND THE IMAGES WERE UPSIDE DOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 0

    PER THE CUSTOMER, THERE WAS AN ISSUE WITH THE SYSTEM LOADING IMAGES. THE LOADING WAS DELAYED BY SEVERAL MINUTES AND THE IMAGES WERE UPSIDE DOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449635 SCOPIS ENT SOFTWARE WITH TGS NEUROLOGICAL STEREOTAXIC INSTRUMENT PGW STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 8000-020-002 N/A 07613327413199

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown