OPMI PICO ON S100 FLOOR STAND

Additional Manufacturer Narrative

NARRATIVE: ZEISS RECORDS INDICATE THAT THERE IS NO SERVICE CONTRACT OR SERVICE HISTORY FOR THE MICROSCOPE IN QUESTION. THE HCP CONFIRMED THAT THE LAST SERVICE WAS DONE MORE THAN 7 YEARS AGO. A FIELD SERVICE ENGINEER PERFORMED AN ON-SITE INSPECTION OF THE MICROSCOPE AND FOUND THAT THE PNEUMATIC SPRING WAS LEAKING AND DID NOT HOLD POSITION. THE USER MANUAL G-30-1385-EN, ISSUE 5.0, PRINTED ON 14. 05. 2001, ADVISES ON SEVERAL PAGES TO CONTACT SERVICE, IF A FUNCTION OF THE MICROSCOPE FAILS, E.G. PAGE 16, 38, 42. THE USER MANUAL INFORMS ABOUT A REGULAR MAINTENANCE INTERVAL OF EVERY 24 MONTHS FOR THE SUSPENSION SYSTEM. THE MANUFACTURER'S CONCLUSION IS THAT NORMAL USE AND NORMAL MAINTENANCE AND REPAIR FOLLOWING ZEISS PROCEDURES COULD NOT LEAD TO THE OCCURRED SCOPE ARM DROP. THE USER MANUAL ADVISES ON PAGE 103 TO PERFORM A DETAILED FUNCTION CHECK BEFORE SURGERY AND WITHOUT PATIENT PRESENT. THIS CONTAINS UNDER TITLE "SETTING THE SUSPENSION ARM WEIGHT COMPENSATION" ALSO THE PROPER BALANCING OF THE MICROSCOPE.

Description of Event or Problem

THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THE OPMI PICO MICROSCOPE ARM WAS IN THE UPPER STANDBY POSITION WHEN DROPPING SUDDENLY ABOUT TWO FEET. THE SCOPE HEAD HIT THE PATIENT ABOVE THE LEFT EYEBROW. THE HCP DESCRIBED THE RESULTING ABRASION AS "SUPERFICIAL" AND CONFIRMED THAT NO MEDICAL INTERVENTION WAS NEEDED. THE SCOPE WAS USED FOR ROUTINE EXAMINATION OF PATIENT'S EARS. THE EXAMINATION WAS COMPLETED SUCCESSFULLY.