BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINAC

    MDR report key: 841259 · Received April 23, 2007

    Report

    Report Number
    2914292-2007-00021
    Event Type
    Injury
    Date Received
    April 23, 2007
    Date of Event
    April 9, 2007
    Report Date
    April 10, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT HAS BEEN RECOGNIZED AS USE ERROR BY VARIAN MEDICAL SYSTEMS. LABELING PLACED ON THE COUCH, AS WELL AS IN THE USER MANUAL, PROVIDE INSTRUCTION AND EXPLICIT HAZARD WARNINGS (WITH RESPECT TO HAND PLACEMENT), WHICH HELP TO ENSURE THE SAFE OPERATION OF THE EQUIPMENT. CAPA HAS BEEN OPENED IN ORDER TO ADDRESS POSSIBLE PRODUCT IMPROVEMENTS TO PREVENT ANY FUTURE PINCH-POINT INJURIES.

    Description of Event or Problem · 1

    THERAPISTS WERE MANUALLY MOVING THE COUCH TO THE TREATMENT POSITION WITH A PT ON THE TABLE. A THERAPISTS' HAND WAS GRASPING THE UNDERSIDE OF THE TABLE AND AS THE TABLE REACHED THE BASE HER SMALL 5TH FINGER AT THE DISTAL END WAS SEVERED BY A PINCH POINT ON THE UNDERSIDE OF THE COUCH. THE THERAPIST WAS TAKEN TO THE EMERGENCY ROOM WHERE PLASTIC SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS EXACT COUCH/2100EX *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| S