BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTHEAD F628

    MDR report key: 22789907 · Received August 12, 2025

    Report

    Report Number
    0008010153-2025-00006
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 15, 2025
    Report Date
    December 16, 2025
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 15 JULY 2025, IT WAS REPORTED BY THE TECHNICIAN THAT THE BLUE DOME COVER OF THE F628 LIGHT WAS CRACKED AND HAD FALLEN. TO RESECURE THE DEVICE, THE CUSTOMER HAD ATTEMPTED TO DRILL SELF-TAPPING SCREWS INTO THE COVER. THE ISSUE WAS RESOLVED BY REPLACING THE DOME COVER WITH A NEW UNDAMAGED COVER. THE MOST LIKELY ROOT CAUSE IS A COMBINATION OF CUSTOMER MISUSE AND NORMAL PRODUCT WEAR. THIS IS SUPPORTED BY THE EVIDENCE OF REATTACHMENT AND SELF DRILLING SCREWS, WHICH IRREPARABLY DAMAGED THE PRODUCT; HOWEVER, THIS ACTION WAS IN RESPONSE TO CRACKING IN THE DOME COVER, WHICH LIKELY FAILED DUE TO A COMBINATION OF AGE (THE DEVICE IS AN OLDER BERCHTOLD MODEL, WHICH WERE PHASED OUT FOR THE UPDATED STRYKER BRANDED F628 LIGHTS IN 2019) AND ENVIRONMENTAL FACTORS. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT. THERE WERE NO ADVERSE EVENTS REPORTED. THIS FAILURE DID NOT EXCEED ANY THRESHOLDS AND WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLUE DOME COVER ON THE LIGHT IN 12C L&D ROOM HAS FALLEN OFF AT SOME POINT. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLUE DOME COVER ON THE LIGHT IN 12C L&D ROOM HAS FALLEN OFF AT SOME POINT. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258914 LIGHTHEAD F628 LIGHT, SURGICAL, CEILING MOUNTED FSY BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown