OPMI PENTERO

Description of Event or Problem

THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT HAD A THIRD DEGREE BURN ON THE LEFT WRIST IMMEDIATELY AFTER A RADIOCEPHALIC ARTERIOVENOUS FISTULA CREATION PROCEDURE USING AN OPMI PENTERO MICROSCOPE. THE BURN WAS 5CM X 3.5 CM AROUND THE SURGICAL AREA AND INCLUDED THE SURGICAL AREA. WOUND CARE WAS ADMINISTERED. SUBSEQUENT CONSULT TO PLASTIC SURGERY HAS REQUIRED AN ADDITIONAL SURGICAL PROCEDURE FOR EXCISIONAL DEBRIDEMENT AND FULL THICKNESS SKIN GRAFT. ALL PERTINENT INFORMATION AVAILABLE TO CARL ZEISS MEDITEC HAS BEEN SUBMITTED IN THIS REPORT.

Additional Manufacturer Narrative

A FIELD SERVICE ENGINEER (FSE) PERFORMED AN ON-SITE INSPECTION OF THE MICROSCOPE AND ITS LIGHT FUNCTION. NO FAILURE WAS DETECTED THAT COULD LEAD TO THE REPORTED INJURY. THE ACTUAL LIGHT INTENSITY SETTINGS USED DURING THE SURGERY COULD NOT BE DETERMINED AS THE MICROSCOPE HAD BEEN ACCESSED PRIOR TO THE FSE'S INSPECTION. THE MANUFACTURER'S INVESTIGATION OF THE DEVICE LOG SHOWED NO ERROR DURING SYSTEM USE. THE SITE REPORTED A SMALL WORKING DISTANCE OF 12-14 INCHES FROM THE SKIN OF AN ADOLESCENT PATIENT. THE SITE ALSO REPORTED THAT THE AREA AROUND THE INCISION WAS NOT PROTECTED BY AN INCISION DRAPE DURING THE 50-60 MINUTES OF LIGHT EXPOSURE. THE SITE FURTHER REPORTED THAT THE HEALTH CARE PROFESSIONAL WAS NOT TRAINED TO USE THE MICROSCOPE AND WAS NOT AWARE OF THE RELEVANCE OF CAREFUL LIGHT SETTINGS. THE USER MANUAL (G-30-1458-EN, ISSUE 6.1) EXPLAINS IN DETAIL THE NUMEROUS FACTORS THAT CAN INFLUENCE THE RISK OF BURNS, INCLUDING BUT NOT LIMITED TO, LIGHT INTENSITY, WORKING DISTANCE, SIZE OF ILLUMINATED FIELD, DURATION OF EXPOSURE, AND PATIENT SKIN TYPE. DESCRIPTION OF FURTHER UPDATES: (B)(4).