OPMI MOVENA

Description of Event or Problem

IT WAS REPORTED THAT THE SURGEON TURNED AWAY FROM THE OPMI MOVENA MICROSCOPE DURING A SURGICAL PROCEDURE AND THE MICROSCOPE HEAD (BEAM SPLITTER, STEREO CO-OBSERVATION TUBE, STRAIGHT BINOCULARS, C-MOUNT LENS AND CAMERA) FELL ON TO THE PATIENT'S CHEST. IT WAS FURTHER REPORTED THAT PATIENT DID NOT SUSTAIN A WOUND OR SERIOUS INJURY.

Additional Manufacturer Narrative

A ZEISS REPRESENTATIVE DETERMINED THAT THE MICROSCOPE HEAD FELL DUE TO A LOOSE SECURING SCREW. THE MICROSCOPE USER MANUAL AND MICROSCOPE INTERFACE MANUAL INSTRUCT THE USER TO CHECK SCREWED CONNECTIONS BEFORE EACH USE. THESE INSTRUCTIONS INCLUDE PICTURES AND WARNING SYMBOLS. THE REQUIREMENTS FOR OPERATION INCLUDE THE STATEMENT: "ALL MECHANICAL CONNECTIONS (DETAILS IN THE USERS MANUAL) WHICH ARE RELEVANT TO SAFETY ARE PROPERLY CONNECTED AND SCREW CONNECTIONS TIGHTENED." THE SECTION FOR THE BINOCULAR TUBE INCLUDES THE STATEMENT: "ATTACH BINOCULAR TUBE (5) TO THE MICROSCOPE BODY AND FIRMLY TIGHTEN SECURING SCREW (4)." (B)(6).