OPMI LUMERA T

Description of Event or Problem

AFTER SURGERY WAS COMPLETED, THE STAFF ATTEMPTED TO DETACH THE RESIGHT AND THE MICROSCOPE FELL. THERE WAS NO PATIENT AFFECTED AS THE PATIENT WAS NO LONGER PRESENT. NO IMPACT TO USER OR ANY OTHER THIRD PARTY.

Additional Manufacturer Narrative

IT WAS CONFIRMED BY A ZEISS FIELD SERVICE ENGINEER THAT THE OPMI INCLUDING THE XY COUPLING DID FALL. BEFORE DELIVERY, THE OPMI WITH THE XY COUPLING IS REMOVED FROM THE SUSPENSION ARM AND ENCLOSED WITH THE DEVICE IN THE DELIVERY. DURING INSTALLATION AT THE CUSTOMER SITE, THE OPMI WITH THE XY COUPLING IS RECONNECTED TO THE SUSPENSION ARM. ZEISS SERVICE PERFORMS THIS INSTALLATION. MANIPULATION BY THE CUSTOMER IS VERY UNLIKELY TO BE THE CAUSE HERE. SINCE THE INCIDENT WAS PRECEDED BY ANOTHER REPAIR ACTION, IT IS MORE LIKELY THAT THE SECURING SCREW OF THE RETAINING BOLT ON THE XY COUPLING WAS FORGOTTEN TO BE INSTALLED. AXIAL MOVEMENT OF THE MICROSCOPE CAN CAUSE THE RETAINING SCREW TO LOOSEN AND THE MICROSCOPE TO FALL IF THE SECURING SCREW IS NOT PRESENT.