OPMI PENTERO

Additional Manufacturer Narrative

THE MAIN AUTHOR, DR. CARLSON, STATED THAT THERE WAS NO ADDITIONAL INFORMATION BEYOND THE ARTICLE. IT WAS REPORTED THAT THE PATIENT WAS EXPOSED TO 135 MINUTES OF ILLUMINATION AT A 100% INTENSITY AND A 250 MM FOCAL LENGTH. THE USER MANUAL EXPLAINS IN DETAIL THE RISKS OF BURNS, INCLUDING 3RD-DEGREE 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. BASED UPON THE INFORMATION IN THE ARTICLE, IT CAN BE CONCLUDED THAT THE SECOND-DEGREE BURN EXPERIENCED BY THE PATIENT WAS THE RESULT OF USE NOT IN ACCORDANCE WIT THE USER DOCUMENTATION.

Description of Event or Problem

THIS IS ONE OF FOUR ADVERSE EVENTS REPORTED IN THE ARTICLE: "AURICULAR BURNS ASSOCIATED WITH OPERATING MICROSCOPE USE DURING OTOLOGIC SURGERY"; LATUSKA, RICHARD F. ET AL.; OTOLOGY & NEUROLOGY 2014; 35:227-233. THIS INFORMATION WAS ORIGINALLY INCLUDED IN MEDWATCH MANUFACTURER REPORT NO. (B)(4) SUBMITTED ON (B)(4) 2014. IN CASE 2, A PATIENT WITH FITZPATRICK SKIN TYPE III UNDERWENT A RIGHT TYMPANOPLASTY WITH ATTICOTOMY AND OSSICULAR CHAIN RECONSTRUCTION FOR PRIMARY ACQUIRED CHOLESTEATOMA USING A OPMI PENTERO MICROSCOPE. THE XENON LIGHT SOURCE WAS USED FOR 135 MINUTES AT 100% INTENSITY AND A 250 MM FOCAL LENGTH. THE FOLLOWING DAY, A SECOND-DEGREE BURN WAS NOTED OVER APPROXIMATELY 70% OF THE POSTERIOR PINNA WITH A DELAYED NONSUPPURATIVE AURICULAR CHONDRITIS OCCURRING DAYS LATER. THE PATIENT WAS MANAGED WITH A COURSE OF PROPHYLACTIC ORAL ANTIBIOTICS AND DAILY DRESSING CHANGES USING OCCLUSIVE PETROLATUM GAUZE UNTIL RESOLUTION. THE OUTCOME: RESOLVED WITHOUT COSMETIC DEFECT.