THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THE FOLLOWING: WHILE PERFORMING A ROOT CANAL PROCEDURE, THE OPMI PICO MICROSCOPE HEAD DROPPED DOWN ABRUPTLY ABOUT 6 INCHES AND MADE CONTACT WITH THE PATIENT'S NOSE. THE DOCTOR WAS HOLDING THE MICROSCOPE HEAD AT THE TIME OF THE EVENT, THEREFORE, THE PATIENT DID NOT EXPERIENCE THE FULL IMPACT OF THE DROP. THE PATIENT WAS NOT INJURED. THE HCP TIGHTENED THE TENSION KNOB ON THE SUSPENSION ARM AND COMPLETED SUCCESSFULLY THE CASE BY USING THE SAME MICROSCOPE AS IT MAINTAINED ITS BALANCE UNTIL A CERTAIN DISTANCE.
N
Patient 1
THE MANUFACTURER (B)(4) DETERMINED THAT THE ROOT CAUSE OF THE DROPPING SCOPE ARM OF THE OPMI PICO ON S100 WALL MOUNT MICROSCOPE SYSTEM WAS DUE TO THE PNEUMATIC SPRING IN THE SCOPE ARM LOSING ITS TENSION OVER THE TIME. THE PNEUMATIC SPRING WAS SEND TO THE SPRING MANUFACTURER FOR INVESTIGATION. THE SPRING MANUFACTURER DETERMINED THAT THE TENSION OF THE SPRING WAS BELOW SPECIFICATION, WHICH IS NORMAL FOR THE AGE OF THIS SPRING WITH 10 YEARS. THE SPECIFICATION OF THE TENSION IS 1520 N AS A MINIMUM AND THE VALUE OF THE RETURNED SPRING WAS BELOW 1371 N. THE SPRING MANUFACTURER CONFIRMED THAT THE PNEUMATIC SPRING LOSING ITS TENSION OVER THE TIME IS PART OF THE NATURAL AGING PROCESS AND IS CAUSED DUE TO DIFFUSION OF THE LUBRICATION OF THE PISTON ROD. THIS PROCESS HAPPENS SLOWLY OVER TIME AND WILL BE RECOGNIZED BY THE USER BY NOT BEING ABLE TO BALANCE PROPERLY THE SCOPE ARM. IN THIS CASE, THE DOCTOR ACKNOWLEDGED THAT THE SCOPE ARM OF THE MICROSCOPE HAD NOT BEEN BALANCED FOR A WHILE. THE USER MANUAL INSTRUCTS THE USER TO PERFORM THE FOLLOWING SAFETY MEASURES BEFORE EVERY USE: "ALWAYS CHECK THE FOLLOWING POINTS BEFORE SURGERY (WITHOUT PATIENT) - THE SUSPENSION ARM HAS BEEN PROPERLY BALANCED". "WARNING! IF A FUNCTION FAILS, YOU MUST NOT USE THE INSTRUMENT FOR SAFETY REASONS. CORRECT THE FAULT (SEE THE TROUBLESHOOTING TABLE) OR CONTACT OUR SERVICE DEPARTMENT". ZEISS RECORDS ALSO INDICATE THAT THERE WAS NO ROUTINE MAINTENANCE PERFORMED FOR THE OPMI PICO ON S100 WALL MOUNT IN THE LAST 5 YEARS. THE MANUFACTURER CONCLUDED THAT SAFETY CHECKS AND MAINTENANCE PERFORMED PER USER MANUAL WON'T LEAD TO THE REPORTED ABRUPT DROPPING OF THE SUSPENSION ARM. (B)(4).