BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RONIN X6 OR HEADLIGHT

    MDR report key: 23054567 · Received September 15, 2025

    Report

    Report Number
    MW5176076
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    September 3, 2025
    Report Date
    September 10, 2025
    Manufacturer
    RONIN SURGICAL CORP.
    Product Code
    HPP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A SURGICAL PROCEDURE IN THE OPERATING ROOM, THE RONIN X6 HEADLIGHT WAS USED. TWO SURGEONS WORE HEADLIGHTS THROUGHOUT THE APPROXIMATELY TWO-HOUR SURGERY. UPON COMPLETION OF THE PROCEDURE, IT WAS OBSERVED THAT THE PATIENT'S ABDOMEN--SPECIFICALLY THE AREA EXPOSED OUTSIDE THE STERILE DRAPE--APPEARED DISCOLORED AND SHOWED SIGNS OF SMALL BLISTERING. A CONSULTATION WITH THE PLASTIC SURGERY TEAM WAS CONDUCTED, AND THEY CONFIRMED THAT THE AFFECTED AREA SUSTAINED A BURN INJURY. PATIENT WAS A 13-MONTH-OLD CHILD. BIO ENGINEERING TESTED EVERY RONIN HEADLIGHT THAT WE HAVE ONSITE. NOTHING WAS FOUND TO BE WRONG WITH THE HEADLIGHTS. PEAK INTENSITY: 350,000 LUX ADJUSTABLE SPOT DIAMETER: 5.6" TO 1.5" AT 18" WORKING DISTANCE RUNTIME: 5+ HOURS (EXTENDED BATTERY), 2.5 HOURS (STANDARD BATTERY) WEIGHT: 6.2 OZ LUMINAIRE WIRELESS DESIGN WITH HAPTIC, AUDIBLE, AND VISUAL BATTERY INDICATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640318 RONIN X6 OR HEADLIGHT HEADLAMP, OPERATING, BATTERY-OPERATED HPP RONIN SURGICAL CORP. RK0350

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Female Other