BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 483951 · Received September 11, 2003

    Report

    Report Number
    9710053-2003-00004
    Event Type
    Other
    Date Received
    September 11, 2003
    Date of Event
    June 12, 2003
    Report Date
    September 10, 2003
    Manufacturer
    ALM S.A.
    Product Code
    FTD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE THE LIGHTHEAD AND ARM ASSEMBLY BROKE AND BECAME DETACHED. IT FELL ONTO A PATIENT CAUSING POSSIBLE ABDOMINAL INJURIES. A UROLOGY TABLE WITH A LARGE VERTICAL X-RAY COLUMN WAS POSITIONED DIRECTLY BELOW THE SURGICAL LIGHT AND IS ABLE TO LIFT-UP AND COLLIDE WITH THE LIGHT. THE PROXIMITY OF THE TABLE TO THE SURGICAL LIGHT CONTRIBUTED TO THE EVENT. PREVIOUS CONTACT POINTS (MARKS AND DAMAGE) WERE OBSERVED ON THE LIGHT STRUCTURE AND TOP OF THE X-RAY UNIT, CONFIRMING THESE TYPES OF COLLISIONS HAVE HAPPENED RECENTLY AND OCCASIONALLY OVER TIME. THIS EQUIPMENT INTERFERENCE CAN EXERT EXCESSIVE UPWARD FORCES AGAINST THE LIGHTHEAD AND LIGHT ARMS, RESULTING IN BREAKING THE ARM'S CASTING AND HAVING THE LIGHTHEAD FALL ONTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM SURGICAL LAMP FTD ALM S.A. PRX4301 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other