OPMI LUMERA 700

Additional Manufacturer Narrative

H6: INVESTIGATION FINDINGS CHANGED FROM 3233, RESULTS PENDING COMPLETION OF INVESTIGATION, TO 4248, USAGE PROBLEM IDENTIFIED; INVESTIGATION CONCLUSIONS CHANGED FROM 11, CONCLUSION NOT YET AVAILABLE, TO 19, CAUSE TRACED TO USER. ON 4TH DECEMBER, 2025, A ZEISS TECHNICIAN PERFORMED A SERVICE PREVENTIVE MAINTENANCE VISIT ON CUSTOMER SITE. HE PERFORMED A COMPLETE SYSTEM CHECK OUT. NO SAFETY OR FUNCTIONAL DEFICIENCIES WERE DETECTED; FUNCTIONAL TESTS SUCCESSFULLY COMPLETED. THE DEVICE WORKED TO ZEISS MANUFACTURER SPECIFICATIONS. THE MOST LIKELY ROOT CAUSE WAS AN USER ERROR. IT IS IMPORTANT TO NOTE THAT NEITHER THE DEVICE NOR THE TUBE WAS DEFECTIVE. CONSEQUENTLY, IT IS POSSIBLE THAT THE SCREW WAS NOT PROPERLY TIGHTENED OR CHECKED PRIOR TO THE OPERATION. ON THE SWALLOW MOUNT OF THE LUMERA 700, THERE IS A KNURLED SCREW RESPONSIBLE FOR SECURING THE INVERT TUBE. THIS SCREW MUST BE LOOSENED EACH TIME THE TUBE IS CHANGED AND SUBSEQUENTLY TIGHTENED. TYPICALLY, THE DOCTOR PERFORMS THIS STEP PERSONALLY WHEN SWITCHING TO ANOTHER TUBE.

Description of Event or Problem

IT WAS REPORTED THAT THE MOTORIZED INVERTERTUBE ON THE ASSISTANT MICROSCOPE HAD FALLEN OFF DURING A PROCEDURE IN AUSTRALIA. THE INVERTERTUBE HIT THE PATIENT BEFORE LANDING ON THE FLOOR. A MINOR INJURY (A BRUISE ON THE PATIENT) WAS REPORTED. THE PATIENT WAS ASSESSED BY THE ANESTHETIST WHO TOLD THE STAFF NO MEDICAL ATTENTION WAS REQUIRED. THE SURGERY WAS SUCCESSFULLY COMPLETED AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.