LEICA M844 C40

Additional Manufacturer Narrative

THIS IS A COMBINED INITIAL/FINAL REPORT. OUR FSE ATTENDED THE ROYAL VICTORIA INFIRMARY ON 20 JANUARY, 2020 AND SPOKE TO THE SENIOR MEDICAL ELECTRONICS TECHNICIAN AND THE STAFF NURSE. THE CAUSE OF THE 2ND OBSERVER MODULE WITH CAMERA FALLING DOWN, WAS DUE TO THE GRUB SCREW HOLDING THE UNIT IN PLACE BEING COMPLETELY UNSCREWED. UPON INSPECTION OF THE UNIT, THE FSE FOUND AN E-RING LAYING IN THE OPTICS CARRIER. THIS IS FROM THE GRUB SCREW THAT HOLDS THE 2ND OBSERVER MODULE IN PLACE. THE GRUB SCREW HAD BEEN COMPLETELY UNSCREWED BY THE CUSTOMER CAUSING THE E-RING TO FALL OFF. WHEN SPEAKING TO THE CUSTOMER, THE FSE ASKED IF THEY USE THE VR CAMERA WITH THIS MICROSCOPE. THE CUSTOMER SAID THEY USE THE VR CAMERA OCCASIONALLY AND THEY FIT IT THEMSELVES. TO FIT THE VR CAMERA, THEY NEED TO UNSCREW THE GRUB SCREW AND TAKE OFF THE 2ND OBSERVER MODULE. BASED ON THIS INFORMATION THE FSE CONCLUDED THE FOLLOWING CAUSAL CHAIN: THE CUSTOMER HAS USED THE VR CAMERA IN A PREVIOUS LIST. THE CUSTOMER THEN HAS FITTED THE 2ND OBSERVER MODULE THEMSELVES AS THEY ALWAYS DO AND FORGOT TO TIGHTEN THE GRUB SCREW TO SECURE THE UNIT. CONSEQUENTLY THE 2ND OBSERVER MODULE WAS NOT FIXED PROPERLY AND SUBSEQUENTLY FELL DOWN.

Description of Event or Problem

LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT ON 14 JANUARY, 2020 FROM THE UK STATING THAT AFTER SURGERY WAS COMPLETED AND THE SURGEON MOVED THE MICROSCOPE AWAY FROM THE PATIENT, THE DUAL BINOCULAR UNIT WITH CAMERA BECAME DETACHED FROM THE REST OF THE MICROSCOPE AND FELL ONTO THE PILLOW NARROWLY MISSING THE PATIENT'S HEAD. THERE WAS NO PATIENT / USER INJURY REPORTED. OUR FSE INITIALLY SPOKE WITH THE CUSTOMER WHEN THE CASE WAS OPENED ON THE 14 JANUARY, 2020. HOWEVER, THE CUSTOMER ATTEMPTED TO CONTACT US ON THE 07 JANUARY, 2020 BUT SENT THE EMAIL TO AN INCORRECT EMAIL ADDRESS, HENCE THE DELAY IN LEICA MICROSYSTEMS BEING INFORMED.