BEUDAMED
    FDA Adverse Event Other Summary report: N

    MODEL D STANDARD MULTIPURPOSE ARC

    MDR report key: 108530 · Received July 25, 1997

    Report

    Report Number
    9612186-1997-00002
    Event Type
    Other
    Date Received
    July 25, 1997
    Date of Event
    June 9, 1997
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    HAW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MODEL D ARC WAS SUPPLIED TO THE HOSPITAL IN ERROR FOR USE WITH THEIR MODEL G STEREOTACTIC FRAME, CAUSING MEASUREMENT ERRORS DURING STEREOTACTIC PROCEDURES. THE ERROR WAS NOT REALIZED BY HOSP PERSONNEL UNTIL AFTER A REPORTED FIVE PT TREATMENTS DURING THE PERIOD OF JUNE 9, THROUGH JUNE 27, 1997. AS OF THIS REPORT, NO NEGATIVE OUTCOMES WERE ATTRIBUTED TO TWO PTS; ONE PT UNDERGOING A BIOPSY RESULTED IN AN INEFFECTVIE BIOPSY; AND THE STATUS OF TWO PTS IS UNK AS OF THIS DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL D STANDARD MULTIPURPOSE ARC LEKSELL STEREOTACTIC SYSTEM HAW ELEKTA INSTRUMENT AB MODEL D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other