RONIN X6

Description of Event or Problem

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

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.