BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 385504 · Received March 28, 2002

    Report

    Report Number
    385504
    Event Type
    Other
    Date Received
    March 28, 2002
    Date of Event
    March 22, 2002
    Report Date
    March 28, 2002
    Manufacturer
    SKYTRON SURGICAL
    Product Code
    FSY
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, DOCTOR ATTEMPTED TO ADJUST OVERHEAD LIGHT. THE LIGHT DISENGAGED, CAUSING THE LIGHT TO DROP SUDDENLY. THE LIGHT WAS CAUGHT BEFORE IT WAS ABLE TO TOUCH PT. IF IT HAD NOT BEEN CAUGHT IT COULD HAVE SERIOUSLY INJURED PT OR STAFF. MFR'S REP REPORTED THE ASSEMBLY HAD LOST ITS SPRING TENSION BECAUSE THE SPRING RETAINER NUT WAS LOOSE. ANALYSIS OF HARDWARE REVEALED THAT A "TOO LONG" SCREW MADE CONTACT WITH BALANCE SPRING NUT ALLOWING IT TO SWING FREELY. THE RETAINER NUT "UNSCREWED" AS THE SHAFT TURNED. THE SPRING AND NUT REMAINED STATIONARY. MFR RECREATED SITUATION AT FACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SURGICAL OVERHEAD LIGHT FIXTURE FSY SKYTRON SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other