BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RONIN X6

    MDR report key: 11116235 · Received January 5, 2021

    Report

    Report Number
    11116235
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    November 2, 2020
    Report Date
    December 28, 2020
    Manufacturer
    RONIN SURGICAL CORP.
    Product Code
    HPP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 0

    DURING A LAMINECTOMY PROCEDURE, THE SURGEON NOTED BURNING AT THE SURGICAL INCISION SITE WHILE USING A PORTABLE HIGH INTENSITY LED SURGICAL HEADLAMP SYSTEM. THE SURGEON DISCONTINUED USE OF HEADLAMP AND PROCEEDED WITH COMPLETION OF SURGERY WITHOUT ADDITIONAL COMPLICATIONS. FOLLOW UP WITH PATIENT OCCURRED TO NOTE PROGRESS OF SKIN HEALING. NO ADDITIONAL INTERVENTIONS REQUIRED. DURING DISCUSSION WITH ANOTHER SURGEON IT WAS DISCOVER THAT AN ADDITIONAL SURGEON NOTED BURNING AT THE INCISION SITE ON THEIR UNRELATED PROCEDURE. TWO HEADLAMP ASSEMBLIES SENT TO BIOMEDICAL ENGINEERING DEPARTMENT FOR EVALUATION AND REPORTING. BIOMEDICAL ENGINEERING TESTING OF THE HEADLAMP ASSEMBLIES NOTED SIGNIFICANT WARMING AND HEATING OF A TARGET AREA WHEN MEASURED WITH AN ELECTRONIC THERMISTOR-BASED THERMOMETER. BIOMEDICAL ENGINEERING ALSO WAS ABLE TO BURN AND SINGE A NON-REFLECTIVE SURFACE DURING TESTING OF THE LAMP SYSTEM. BIOMEDICAL ENGINEERING TO CONTACT MANUFACTURER FOR FOLLOW UP. MANUFACTURER RESPONSE FOR LED SURGICAL LIGHT HEADLAMP, RONIN X6 (PER SITE REPORTER). CONTACTED MANUFACTURER AND WILL FOLLOW UP WITH REPORTING AND DOCUMENTING EVENT. INFORMED MANUFACTURER THAT HEADLAMPS WERE PULLED FROM SERVICE, PENDING ROOT CAUSE.

    Description of Event or Problem · 1

    DURING A LAMINECTOMY PROCEDURE, THE SURGEON NOTED BURNING AT THE SURGICAL INCISION SITE WHILE USING A PORTABLE HIGH INTENSITY LED SURGICAL HEADLAMP SYSTEM. THE SURGEON DISCONTINUED USE OF HEADLAMP AND PROCEEDED WITH COMPLETION OF SURGERY WITHOUT ADDITIONAL COMPLICATIONS. FOLLOW UP WITH PATIENT OCCURRED TO NOTE PROGRESS OF SKIN HEALING. NO ADDITIONAL INTERVENTIONS REQUIRED. DURING DISCUSSION WITH ANOTHER SURGEON IT WAS DISCOVER THAT AN ADDITIONAL SURGEON NOTED BURNING AT THE INCISION SITE ON THEIR UNRELATED PROCEDURE. TWO HEADLAMP ASSEMBLIES SENT TO BIOMEDICAL ENGINEERING DEPARTMENT FOR EVALUATION AND REPORTING. BIOMEDICAL ENGINEERING TESTING OF THE HEADLAMP ASSEMBLIES NOTED SIGNIFICANT WARMING AND HEATING OF A TARGET AREA WHEN MEASURED WITH AN ELECTRONIC THERMISTOR-BASED THERMOMETER. BIOMEDICAL ENGINEERING ALSO WAS ABLE TO BURN AND SINGE A NON-REFLECTIVE SURFACE DURING TESTING OF THE LAMP SYSTEM. BIOMEDICAL ENGINEERING TO CONTACT MANUFACTURER FOR FOLLOW UP. MANUFACTURER RESPONSE FOR LED SURGICAL LIGHT HEADLAMP, RONIN X6 (PER SITE REPORTER). CONTACTED MANUFACTURER AND WILL FOLLOW UP WITH REPORTING AND DOCUMENTING EVENT. INFORMED MANUFACTURER THAT HEADLAMPS WERE PULLED FROM SERVICE, PENDING ROOT CAUSE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16706 RONIN X6 HEADLAMP, OPERATING, BATTERY-OPERATED HPP RONIN SURGICAL CORP. X6

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA