OPMI PICO ON S100 CEILING MOUNT WITH MORA

Description of Event or Problem

AN OPMI PICO MICROSCOPE WAS SUSPENDED FROM AN S100 CEILING MOUNT; THE MICROSCOPE WAS EQUIPPED WITH BINOCULARS AND AN OPTIONAL "MECHANICAL OPTICAL ROTATING ASSEMBLY" (MORA) INTERFACE. WHILE AN ADULT MALE WAS BEING EXAMINED, THE BINOCULARS AND MORA INTERFACE FELL AND HIT THE PATIENT ON THE TOP OF THE HEAD. THE DOCTOR PLACED FIVE SUTURES ON THE PATIENT. THE PATIENT PLANNED TO GO TO A HOSPITAL AFTER THIS INCIDENT OCCURRED. THE PATIENT HAS BEEN SEEN IN THE OFFICE AFTER THE INCIDENT OCCURRED AND IS REPORTED TO BE DOING WELL.

Additional Manufacturer Narrative

THE MICROSCOPE WAS INSTALLED (B)(4) 2008 BY CZMI; THE OPTIONAL MORA INTERFACE IS A PRODUCT UPGRADE THAT WAS SUBSEQUENTLY INSTALLED, HOWEVER, IT IS NOT CLEAR WHO INSTALLED THE MORA INTERFACE OR WHEN. UPON EVALUATING PHOTOGRAPHS OF THE SYSTEM, THE MANUFACTURER DETERMINED THAT THE MORA INTERFACE WAS NOT PROPERLY INSTALLED ACCORDING TO MANUFACTURER INSTRUCTIONS IN USER MANUAL AND INSTALLATION MANUAL. THE ARM OF THE SUSPENSION SYSTEM WAS CONNECTED DIRECTLY TO THE MICROSCOPE BODY INSTEAD OF TO THE MORA INTERFACE. A FIELD SERVICE ENGINEER (FSE) EVALUATED THE MICROSCOPE ON (B)(4) 2011. ALL OF THE THREADS AND SCREWS OF THE MORA INTERFACE AND BINOCULARS WERE INSPECTED; NO DAMAGE WAS FOUND. THE FSE REINSTALLED THE MICROSCOPE TO THE CORRECT CONFIGURATION AND APPLIED LOCKTITE TO SCREWS AND YOKE SCREWS. THE FSE TESTED THE OPTICS AND ALL SAFETY SCREWS ON THE MOUNTING SYSTEM, CLEANED THE LENS, AND CHECKED BALANCE OF THE MICROSCOPE. THE FSE DETERMINED THAT THE MICROSCOPE WAS FULLY FUNCTIONAL.