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 CONCLUDED THAT THE ROOT CAUSE OF THE OPTICAL HEAD FALLING THE SECOND TIME IS DUE TO USER ERROR. IMMEDIATELY AFTER RECEIVING THE FIRST REPORT OF THE OPTICAL HEAD FALLING ON (B)(6) 2017, THE DOCTOR WAS ADVISED BY THE LOCAL ZEISS DISTRIBUTOR NOT TO USE THE SYSTEM UNTIL THE DEVICE IS REPAIRED BY ZEISS SERVICE, WHICH WAS PLANNED FOR AND PERFORMED ON (B)(6) 2017. HOWEVER, THE DOCTOR DECIDED TO RE-MOUNT THE OPTICAL HEAD OF THE MICROSCOPE ONTO THE STAND AND PROCEEDED TO USE THE DEVICE AGAIN BEFORE IT COULD BE REPAIRED. THE USER MANUAL (G-30-1781-EN, VERSION 7.1, 2016-03-09, PAGE 10 AND 11) STATES "THE CORRECT USE OF THE DEVICE IS ABSOLUTELY VITAL FOR SAFE OPERATION. THEREFORE, PLEASE THOROUGHLY FAMILIARIZE YOURSELF WITH THE CONTENT OF THESE INSTRUCTIONS FOR USE BEFORE STARTING UP THE SYSTEM". "MODIFICATIONS AND REPAIRS ON THIS DEVICE OR ANY EQUIPMENT OPERATED TOGETHER WITH THIS DEVICE MAY ONLY BE PERFORMED BY ZEISS SERVICE." THE USER MANUAL (G-30-1781-EN, VERSION 7.1, 2016-03-09, PAGE 15, 208) FURTHER ADVISES THAT "IF A FAILURE OCCURS WHICH YOU CANNOT CORRECT WITH THE AID OF THE CHAPTER 'WHAT TO DO IN THE EVENT OF MALFUNCTIONS', ATTACH A SIGN TO THE DEVICE STATING IT IS OUT OF ORDER AND CONTACT OUR SERVICE REPRESENTATIVE."

Description of Event or Problem

THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT ON (B)(6) 2017, DURING A PROCEDURE THE OPTICAL HEAD OF THE OPMI PICO ON A S100 FLOOR STAND BECAME COMPLETELY LOOSE. THE DOCTOR WAS ABLE TO CATCH THE FALLING HEAD PREVENTING IT FROM HITTING THE FLOOR OR ANY PERSON. THE DOCTOR MOUNTED THE OPTICAL HEAD BACK ONTO THE STAND AND COMPLETED THE PROCEDURE SUCCESSFULLY WITH THE SAME MICROSCOPE. NO ONE WAS INJURED DUE TO THIS INCIDENT. THE HCP REPORTED THE SAME PROBLEM OF THE FALLING OPTICAL HEAD THE PREVIOUS DAY TO THE LOCAL ZEISS DISTRIBUTOR AND WAS ADVISED NOT TO USE THE SYSTEM UNTIL IT IS REPAIRED, WHICH WAS PLANNED FOR AND PERFORMED ON (B)(6) 2017. THAT INCIDENT IS REPORTED UNDER MDR #9615010-2017-00005.