BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRW-FN W/UCLF LOCALIZER

    MDR report key: 139016 · Received December 15, 1997

    Report

    Report Number
    1219140-1997-00015
    Event Type
    Other
    Date Received
    December 15, 1997
    Date of Event
    November 7, 1997
    Report Date
    December 5, 1997
    Manufacturer
    RADIONICS, INC.
    Product Code
    HAW
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NEUROSURGEON WAS PERFORMING STEREOTACTIC BIOPSY USING CRW ARC SYS. PT WAS SCANNED WITH UCLF. TARGET COORDINATES WERE CALCULATED FOR A DIFFERENT LOCALIZER GEOMETRY. THE NEEDLE WAS INSERTED AT INCORRECT LOCATION, APPROX 3 CM OFF. NEUROSURGEON WAS PROVIDED WITH CORRECT COORDINATES, AND PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRW-FN W/UCLF LOCALIZER STEREOTACTIC SYSTEM HAW RADIONICS, INC. CRW-FN/UCLF *

    Patients

    Seq Age Sex Outcome Treatment
    1 *