OPMI PICO

Description of Event or Problem

IT WAS REPORTED THAT DURING AN EAR MICROSCOPY CASE IN GERMANY, THE ARM OF THE OPMI PICO MICROSCOPE SAGGED, CAUSING THE MICROSCOPE HEAD TO FALL TOWARD THE PATIENT'S HEAD. THE INCIDENT RESULTED IN A MINOR LACERATION OF THE PATIENT THAT WAS TREATED IMMEDIATELY BY THE DOCTOR. THE OPERATION WAS FINISHED USING A NEIGHBORING EXAMINATION UNIT WITH NO SIGNIFICANT DELAY IN COMPLETING THE CASE DUE TO THE PROBLEM ENCOUNTERED. PRIOR TO THE OPERATION, THE DEVICE WAS BALANCED AND NO ADDITIONAL WEIGHT WAS ADDED TO THE MICROSCOPE HEAD.

Additional Manufacturer Narrative

ACCORDING TO THE IFU G-30-1781-DE, THE USER MUST CHECK THE DEVICE BEFORE EVERY USE (SECTION "SAFETY MEASURES" & "BEFORE EACH OPERATION"). IN PARTICULAR, THE USER IS ASKED TO CHECK THAT COMPONENTS AND THEIR SECURING SCREWS ARE SECURED PRIOR TO EVERY USE. THE PROBABILITY OF OCCURRENCE OF A SUCH AN INCIDENT CAN BE REDUCED BY PERFORMING A DEVICE CHECK BEFORE EACH PROCEDURE. THE USER IS INSTRUCTED TO TAKE ADEQUATE PRECAUTIONS, DEPENDING ON THE APPLICATION, TO ENABLE THE SURGICAL PROCEDURE OR TREATMENT TO BE FINISHED WITHOUT USING THE DEVICE IN CASE OF A HARDWARE OR SOFTWARE FAILURE (SECTION "OPERATION" & "FUNCTIONAL CHECK BEFORE USE"). THE LAST SERVICE REPAIR WAS CONDUCTED IN JANUARY 2023, DURING WHICH IT WAS CONFIRMED THAT THE SYSTEM MEETS ZEISS SPECIFICATIONS. SINCE THEN, ZEISS HAS CONDUCTED NO FURTHER SERVICE VISIT. IT IS ASSUMED THAT THE DEVICE HAS BEEN USED SINCE THEN, WHICH RAISES THE POSSIBILITY THAT THE USER HAS MADE ADJUSTMENTS OR MODIFICATIONS. IT IS UNLIKELY THAT THE SCREW WOULD LOOSEN ON THEIR OWN, AS THEY ARE DESIGNED TO REMAIN SECURE UNDER NORMAL OPERATING CONDITIONS. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THE LOOSE SCREW APPEARS TO BE A USER ERROR.