OPMI PICO WITH S100 FLOOR STAND

Additional Manufacturer Narrative

A COPY OF MEDWATCH REPORT DATED (B)(6) 2015 PERTAINING TO THE INCIDENT DESCRIBED IN SECTION 5A WAS RECEIVED FROM THE SITE ON (B)(6) 2015. EVALUATION: ZEISS RECORDS INDICATE THAT THERE IS NO SERVICE CONTRACT OR SERVICE HISTORY FOR THE MICROSCOPE IN QUESTION. THE SITE'S REPRESENTATIVE CONFIRMED THAT THEY HAD A CONTRACT WITH A 3RD PARTY TO PERFORM MAINTENANCE AND REPAIR FOR THE MICROSCOPE. ON (B)(6), 2015 A FIELD SERVICE ENGINEER PERFORMED AN ON-SITE INSPECTION OF THE MICROSCOPE AND FOUND THE GAS STRUT MOUNTING BRACKET HAD ALREADY BEEN REPAIRED BY A 3RD PARTY TECHNICIAN. THE MANUFACTURER'S INVESTIGATION CONCLUDED THAT THE SYSTEM IS DESIGNED SO THAT THERE ARE NO LATERAL FORCES THAT WOULD CONTRIBUTE TO THE OBSERVED BENDING OF THE BRACKET. THE MANUFACTURER'S CONCLUSION IS THAT NORMAL USE AND NORMAL MAINTENANCE AND REPAIR FOLLOWING ZEISS PROCEDURES COULD NOT LEAD TO THE OBSERVED BRACKET BENDING.

Description of Event or Problem

ADDITIONAL INFORMATION: THE HEALTHCARE PROVIDER REPORTED THAT THE BRACKET WITH THE GAS STRUT RETAINING SLOT, WHICH IS MOUNTED TO THE FLOOR STAND ARM, WAS BENT OUTWARDS. THE INCIDENT HAPPENED WHILE THE DOCTOR WAS ABOUT TO PERFORM AN EAR MICROSCOPY EXAM. THE PATIENT WAS AWAKE AT THE TIME, NOT UNDER ANESTHESIA AND NOT IN THE POSITION TO PERFORM THE EXAM. THERE WAS NO INJURY TO THE PATIENT OR DOCTOR. REFERENCE MW 504192.