BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAYPOINT STEREOTACTIC SYSTEM

    MDR report key: 12160501 · Received July 13, 2021

    Report

    Report Number
    3002250546-2021-00002
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Report Date
    July 12, 2021
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    UDI-DI
    00873263005965
    PMA / PMN Number
    K092192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE USING A MP-KIT-P-EO (MULTIOBLIQUE (PMT) WAYPOINT STEREOTACTIC SYSTEM, PHYSICIAN FOUND THE PLATFORM WAS LABELED WITH THE INCORRECT DEPTH NUMBERS. THERE WAS NO HARM TO PATIENT AS PHYSICIAN IDENTIFIED THE ISSUE AND PROCEEDED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054441 WAYPOINT STEREOTACTIC SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW FHC, INC. MP-KIT-P-EO 300185 00873263005965

    Patients

    Seq Age Sex Outcome Treatment
    1