BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RONIN X6

    MDR report key: 23751036 · Received December 8, 2025

    Report

    Report Number
    MW5180139
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 2, 2025
    Manufacturer
    RONIN SURGICAL CORP.
    Product Code
    HPP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A SURGICAL CASE THE PHYSICIAN WAS LOOKING AWAY FROM THE AREA OF HIS HEADLAMP AND THE ARM OF HIS SCRUBS WHERE THE LIGHT WAS UNINTENTIONALLY DIRECTED, BEGAN HEATING AND SMOKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2797494 RONIN X6 HEADLAMP, OPERATING, BATTERY-OPERATED HPP RONIN SURGICAL CORP. X6

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other