BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP

    MDR report key: 10726974 · Received October 23, 2020

    Report

    Report Number
    0002031963-2020-00003
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    September 25, 2020
    Report Date
    October 23, 2020
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A LIGHT HEAD DISENGAGED FROM THE SPRING ARM. THIS OCCURRED DURING A CASE AND IT WAS REPORTED THAT A NURSE WENT TO THE ER FOR A POSSIBLE CONCUSSION. THE ROOT CAUSE OF THE ISSUE WAS MISSING HARDWARE, LIKELY FROM AN UNKNOWN SERVICE PROVIDER. THE LIGHT IS RETAINED BY A SAFETY CLIP THAT IS HELD IN PLACE BY A ROTATED COLLAR. THIS COLLAR IS HELD IN PLACE BY AN M3 SCREW, WHICH UTILIZES A NUT INSIDE THE ARM. THE M3 SCREW AND NUT WERE MISSING AND THE COLLAR WAS RAISED, NO LONGER COVERING THE SAFETY CLIP. THE SAFETY CLIP THEN BACKED OUT. THE HARDWARE WAS VERIFIED UPON INSTALLATION BY STRYKER AND THERE IS NO RECORD OF SERVICE PERFORMED OR REQUESTED FOR THIS UNIT SINCE INSTALLATION. IF ANY FURTHER INFORMATION IS FOUND, A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A LIGHT HEAD FELL AND HIT AN EMPLOYEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194782 EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP LIGHT, SURGICAL, CEILING MOUNTED FSY STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization