BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RITTER

    MDR report key: 23942951 · Received January 2, 2026

    Report

    Report Number
    1523530-2025-00008
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 9, 2025
    Report Date
    January 2, 2026
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    EAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MIDMARK RECEIVED A COMPLAINT NOTING THAT A 355-025 PROCEDURE LIGHT CAME DETACHED AT THE BALL JOINT AND FELL DURING USE. THE DR. HELD THE LIGHT UP PREVENTING IT FROM COMING IN CONTACT WITH THE PATIENT. NO INJURY OCCURRED. THE DR. STATED THE OFFICE AND EQUIPMENT WHICH WAS PURCHASED THROUGH DISTRIBUTION WAS NEW IN 2012. HOWEVER, THE SERIAL NUMBER ON THIS LIGHT WAS BUILT ON 4/14/2003 AND SHIPPED FROM MIDMARK ON APRIL 23, 2003.

    Description of Event or Problem · 0

    MIDMARK RECEIVED A COMPLAINT STATING THAT A 355-025 LIGHT CAME APART AT THE BALL JOINT AND FELL. THE DR. HELD THE LIGHT UP PREVENTING IT FROM COMING IN CONTACT WITH THE PATIENT. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10061 RITTER 355 MINOR PROCEDURE LIGHT EAZ MIDMARK CORPORATION 355-025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown