PENTERO 800

Description of Event or Problem

A STAPEDECTOMY EAR SURGERY WAS BEING PERFORMED INVOLVING USE OF A ZEISS PENTERO 800 MICROSCOPE WITH A NOVUS SPECTRA LASER. THE SURGEON USER REPORTED THAT THE LIGHT INTENSITY SEEN THROUGH THE EYEPIECE WAS BECAUSE THE EYEPIECE FILTER WAS NOT IN PLACE. THERE IS A POTENTIAL FOR EYE INJURY TO USERS FROM UNFILTERED EXPOSURE TO LASER FLASHBACK THROUGH THE MICROSCOPE EYEPIECE. IF THE FOVEA IS DAMAGED, IT COULD RESULT IN PERMANENT VISION LOSS. MICROSCOPE DESIGN FEATURES MAKE IT DIFFICULT TO IDENTIFY WHETHER THE FILTER WAS IN PLACE AND THERE IS A LACK OF ERROR PREVENTIONS IN THE SYSTEM. IN THE ZEISS MICROSCOPE MODELS, THE FILTERS ARE PLACED AFTER THE BRANCH, SO EACH EYEPIECE BRANCH REQUIRES A PROTECTIVE FILTER WHEN USED WITH A LASER. THE APPEARANCE OF THE FILTER IN POSITION IS NOT EASY TO DISTINGUISH BY THE TECHNICIAN SETTING UP THE MICROSCOPE OR OTHERS AS IT IS THE SAME COLOR (BLACK) AS THE PIECES AROUND IT. (NOTE: SINCE THE FILTER IS MADE BY ANOTHER MANUFACTURER, WILL ENTER ANOTHER REPORT TO MENTION FILTER EDGE COLOR CODING/LABELING). THE DIFFERENCE IN TIGHTENING KNOBS (BLACK OR SILVER) FOR THE FILTER PIECE VS. OTHER IS NOT READILY NOTICEABLE. DIFFERENT COLOR TIGHTENING KNOBS WOULD BE EASIER TO SEE. IT'S POSSIBLE TO PUT THE PIECES OF THE MICROSCOPE EYEPIECES TOGETHER WITHOUT THE FILTER AND NOT REALIZE IT. THE FILTER PIECES ARE INTERCHANGEABLE AND FIT TOGETHER WITH THE MICROSCOPE AS WELL AS ON TOP OF OTHER FILTERS, SO COULD MISTAKENLY BE DOUBLE STACKED OR MICROSCOPE EYEPIECE PARTS COULD BE CONNECTED WITH NO FILTER. THERE IS NO ALARMING FUNCTION THAT WOULD SHOW ON THE MONITOR/USER INTERFACE WHEN THE FILTER IS NOT DETECTED. IF THERE WAS A SENSOR THAT DETECTED WHETHER THE FILTER WAS IN PLACE BEFORE USE THE TIME OF USE WHEN AN EXPOSURE COULD OCCUR, THIS WOULD PROVIDE VALUABLE FEEDBACK VIA THE USER INTERFACE SCREEN OR COULD PREVENT USERS FROM USING (VIEWING THROUGH THE EYEPIECES) IT UNTIL A FILTER IS CONFIRMED AS IN PLACE. THE ZEISS INSTRUCTIONS FOR USE (IFUS) DO NOT ADDRESS SAFE USE OF THE MICROSCOPE WITH A LASER AND THE NEEDED FILTRATION WHEN VIEWING THROUGH THE EYEPIECES. (NOTE: SINCE THE FILTER IS MADE BY ANOTHER MANUFACTURER, WILL ALSO REVIEW FILTER IFUS).