OPMI PICO ON S100 WALL MOUNT

Additional Manufacturer Narrative

A ZEISS FIELD SERVICE ENGINEER (FSE) PERFORMED AN ON-SITE INSPECTION AND FOUND THAT THE WALL MOUNT PLATE, ON WHICH THE OPMI PICO S100 WALL MOUNT MICROSCOPE SYSTEM WAS MOUNTED, CAME LOOSE AND CAUSED BOTH COMPONENTS, THE WALL MOUNT PLATE AND OPMI PICO MICROSCOPE SYSTEM, DROPPING ON THE FLOOR. THE FSE DID NOT FIND A PROBLEM WITH THE ZEISS RELATED OPMI PICO S100 WALL MOUNT MICROSCOPE INSTALLATION ONTO THE WALL MOUNT PLATE. THE HCP REPORTED THAT THE INSTALLATION OF THE WALL MOUNT PLATE WAS NOT DONE PROPERLY AND WRONG HARDWARE (DRYWALL SCREWS) WAS USED TO SECURE THE WALL MOUNT PLATE TO THE WALL STRUCTURE. THE WALL MOUNT PLATE USED WAS NOT A ZEISS PROVIDED WALL MOUNT PLATE. ZEISS RECORDS CONFIRM THAT THE INSTALLATION OF THE WALL MOUNT PLATE FOR PREPARING THE WALL STRUCTURE WAS DONE PRIOR TO THE OPMI PICO MICROSCOPE SYSTEM INSTALLATION AND IT WAS CONFIRMED TO BE DONE IN ACCORDANCE TO THE PREVIOUSLY PROVIDED SPECIFICATIONS DEFINED IN THE ZEISS PLANNING MANUAL. THE PLANNING MANUAL, (B)(4), VERSION 8.2, (B)(6) 2014, DEFINES THE REQUIREMENTS FOR A SAFE MOUNTING OF THE OPMI PICO S100 WALL MOUNT MICROSCOPE SYSTEM AND GUIDES THE CUSTOMER HOW TO PREPARE THE WALL STRUCTURE. THE MANUAL CONTAINS A COMPLETE SECTION WITH "CUSTOMER'S PREPARATORY RESPONSIBILITIES" IN ORDER ENSURE A SAFE WALL STRUCTURE PREPARATION BY THE CUSTOMER. THE DOCUMENT ADVISES ON PAGE 82 ABOUT THE WALL MOUNT INSTALLATION INCLUDING A WARNING SIGN THE WALL MOUNT MUST ONLY BE INSTALLED ON THE ORIGINAL WALL FLANGE OR, IF NECESSARY, ON THE ORIGINAL WALL PLATE FROM CARL ZEISS."

Description of Event or Problem

THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE SUPPORTING WALL MOUNT PLATE, ON WHICH THE OPMI PICO WITH S100 WALL MOUNT MICROSCOPE SYSTEM WAS MOUNTED, CAME LOOSE FROM THE WALL AND THE WALL MOUNT PLATE AND THE WHOLE OPMI PICO MICROSCOPE DROPPED ON THE FLOOR. AT THE TIME OF THE INCIDENT, NO ONE USED THE MICROSOPE AND NO PATIENT WAS INVOLVED. THERE WAS NO INJURY.