OPMI PENTERO

Additional Manufacturer Narrative

NARRATIVE: A FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT, INCLUDING LIGHT SETTING FUNCTIONS, AND CONFIRMED THAT THE INSTRUMENT OPERATES WITHIN MANUFACTURER SPECIFICATIONS. THE USER MANUAL EXPLAINS IN DETAIL THE RISK OF BURNS CAUSED BY HIGH ILLUMINATION INTENSITY. THE USER MANUAL INSTRUCTS THE USER TO SET THE ILLUMINATION INTENSITY TO THE MINIMUM VALUE REQUIRED WITH 25% RECOMMENDED AS A STARTING VALUE. A VISUAL WARNING CAN BE DISPLAYED WHEN AN ILLUMINATION THRESHOLD VALUE IS EXCEEDED. THE DEFAULT FACTORY THRESHOLD IS SET TO BE ACTIVE WITH A VALUE OF 25%. THE USER MANUAL ALSO DESCRIBES THE CONTRIBUTION OF FOCAL DISTANCE, TIME AND PATIENT SKIN TYPE TO BURNS. FINALLY THE USER MANUAL DISCUSSES THE SUSCEPTIBILITY OF SKIN AROUND THE INCISION TO BURNS WITH A RECOMMENDATION TO USE WET GAUZE IN THE AREA TO REDUCE THE CHANCE OF BURNS. THE HEALTHCARE PROFESSIONAL ADMITTED THAT THIS COULD HAVE BEEN AN USER ERROR AFTER HAVING BEEN ADVISED BY THE FSE ABOUT HOW TO WORK SAFELY WITH THE SCOPE LIGHT.

Description of Event or Problem

THIS IS CASE SIX OF SIX REPORTED CASES OF ORL SURGERY (OTO-RHINO-LARYNGOLOGY) HAVING OCCURRED IN 2014 AND 2015 INVOLVING THE SAME CUSTOMER SITE IN (B)(6) AND THE SAME MICROSCOPE. THE MANUFACTURER RECEIVED INFORMATION FROM THE HEALTHCARE PROFESSIONAL THAT THE PATIENT SUFFERED A SKIN BURN AFTER SURGERY. .IN THIS CASE, THE SURGERY STARTED WITH 20% OF THE LIGHT INTENSITY AND THE SURGICAL AREA WAS WELL FOCUSED. AT THE END OF THE SURGERY, THE HEALTHCARE PROFESSIONAL NOTED A SKIN BURN ASIDE THE FRONT PART OF THE EAR. THE CUSTOMER ALSO DISCOVERED THAT THE LIGHT INTENSITY WAS AT 100% AT THE END OF THE SURGERY NO FURTHER INFORMATION REGARDING PATIENT OR EVENT COULD BE OBTAINED, E.G. ABOUT SEVERITY OF THE SKIN BURN OR POTENTIAL FOLLOW-UP TREATMENT FOR PATIENT.