BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL GAMMA UNIT

    MDR report key: 34864 · Received July 5, 1996

    Report

    Report Number
    1037831-1996-00004
    Event Type
    Malfunction
    Date Received
    July 5, 1996
    Date of Event
    June 16, 1994
    Report Date
    June 25, 1996
    Manufacturer
    ELEKTRA INSTRUMENT AB
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS TO RECEIVE A THREE ISOCENTER TREATMENT OF THE GAMMA KNIFE. THE FIRST SHOT WAS COMPLETED WITHOUT INCIDENT. DURING COUCH WITHDRAWAL ON THE SECOND SHOT, THE BED MOVED OUT TO WITHIN 4" SHORT OF THE FINAL POSITION. THE DOOR DID NOT CLOSE. THE CUSTOMER ATTEMPTED TO CLOSE THE DOOR REMOTELY, BUT THIS DID NOT WORK. PHYSICIAN WENT INTO ROOM AND MANUALLY DREW COUCH TO FINAL POSITION. PT WAS ESCORTED FROM ROOM, AND THE PHYSICIST RETURNED TO HYRDRAULIC ROOM AND USED THE LEVER TO CLOSE THE SHIELDING DOOR. CUSTOMER ATTEMPTED TO CLOSE THE DOOR REMOTELY, BUT THIS DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL GAMMA UNIT RADIATION THERAPY IYX ELEKTRA INSTRUMENT AB 23016 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other 6/16/94 LEKSELL GAMMA UNIT