OPMI PICO ON S100 FLOOR STAND

Additional Manufacturer Narrative

A ZEISS FIELD SERVICE ENGINEER (FSE) PERFORMED AN ON-SITE INSPECTION AND FOUND THAT THE SCREW MECHANISM THAT HOLDS THE OPTICAL HEAD OF THE MICROSCOPE SAFELY TO THE STAND WAS MISSING. THE FSE RE-SECURED THE OPTICAL HEAD ONTO THE STAND WITH THE SCREW MECHANISM AND PUT THE MICROSCOPE BACK INTO SERVICE. THE MANUFACTURER REVIEWED THE DEVICE INSTALLATION PROCESS AND PROCEDURES. THE POLICIES AND PROCEDURES ESTABLISHED FOR REGULAR TRAINING AND CONTROL OF QUALIFICATIONS FOR INSTALLATION AND SERVICE RELATED ACTIVITIES ARE ADEQUATE. THE MANUFACTURER CONCLUDED THAT THE ROOT CAUSE OF THE OPTICAL HEAD FALLING IS IMPROPER INSTALLATION PERFORMED BY A NON-TRAINED PERSON OF THE LOCALLY AUTHORIZED DISTRIBUTOR. THE DISTRIBUTOR WAS NOTIFIED IN WRITING ABOUT THE UNAUTHORIZED INSTALLATION. THE USER MANUAL (G-30-1781-EN, VERSION 7.1, 2016-03-09, PAGE 13) STATES "A ZEISS SERVICE REPRESENTATIVE OR AN EXPERT AUTHORIZED BY ZEISS WILL INSTALL THE SYSTEM".

Description of Event or Problem

THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING EXAMINATION OF A PATIENT'S EAR THE OPTICAL HEAD OF THE OPMI PICO ON A S100 FLOOR STAND BECAME COMPLETELY LOOSE AND FELL OFF. THE MICROSCOPE HEAD MADE CONTACT WITH THE PATIENT'S HEAD RESULTING IN A MINOR BRUISE. THERE WAS NO MEDICAL TREATMENT REQUIRED FOR THE PATIENT. THE DOCTOR MOUNTED THE OPTICAL HEAD BACK ONTO THE STAND AND COMPLETED THE PROCEDURE SUCCESSFULLY WITH THE SAME MICROSCOPE.