BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT SYSTEM DOVERA DM520

    MDR report key: 21790086 · Received April 7, 2025

    Report

    Report Number
    3009028104-2025-00001
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    January 3, 2025
    Report Date
    March 3, 2025
    Manufacturer
    ONDAL MEDICAL SUSTEMS OF AMERICA, INC.
    Product Code
    FSY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ONDAL QUALITY MANAGER WAS INFORMED THAT THE SYSTEM WAS INSTALLED BY A THIRD-PARTY SERVICE PROVIDER. ONDAL CONFIRMED THE EVENT WITH OUR DISTRIBUTOR, SKYTRON. THE CAUSE OF THE EVENT CAN BE ATTRIBUTED TO THE 3RD PARTY IMPROPER INSTALLATION OF THE SECURING SEGMENT AND SECURING SEGMENT LOCKING SCREW. A 3-YEAR COMPLAINT REVIEW INDICATED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THEIR DOVERA LIGHT SYSTEM DETACHED FROM ITS MOUNT. (DUAL LIGHTS FELL OFF MOUNT ONTO FLOOR.) THE EVENT DID NOT OCCUR DURING A PATIENT PROCEDURE, HOWEVER, A HOSPITAL EMPLOYEE SUFFERED A SPRAINED KNEE DURING THE INCIDENT. THE DEVICE WAS REMOVED FROM SERVICE AND SHIPPED BACK TO THE MANUFACTURER FOR INVESTIGATION. A REPLACEMENT DEVICE WAS INSTALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647538 LIGHT SYSTEM DOVERA DM520 LIGHT, SURGICAL, CEILING MOUNTED FSY ONDAL MEDICAL SUSTEMS OF AMERICA, INC. 1949392

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention