LEICA M820 F40

Additional Manufacturer Narrative

THIS IS A COMBINED INITIAL AND FINAL REPORT. PATIENT INFORMATION HAS BEEN REQUESTED. HOWEVER, THE USER FACILITY DECLINED TO PROVIDE THIS INFORMATION TO THE MANUFACTURER DUE TO DATA PRIVACY LAWS IN EU. A SALES REPRESENTATIVE OF LEICA MICROSYSTEMS (B)(4) CHECKED THE CONFIGURATION OF THE DEVICE ON SITE AND TOOK PICTURES. THERE WAS NO DEVICE FAILURE VISIBLE. A TEST MADE AT LEICA MICROSYSTEMS (B)(4) BY SUBJECT MATTER EXPERTS ON A SAMPLE DEVICE SHOWED THAT WHEN FITTING THE STEREO ATTACHMENT TO THE BEAM SPLITTER THERE IS A CLICKING SOUND WHICH INDICATES THAT IT ENGAGED. ONCE THE KNURLED RING IS TIGHTENED THE STEREO ATTACHMENT CANNOT FALL. WE CONCLUDE THAT THE INCIDENT IS CAUSED BY A USER ERROR. THE USER FAILED TO FOLLOW THE INSTRUCTIONS GIVEN IN THE USER MANUAL (LEICA M844 - LEICA M820 / REF. 10 713 294 / VERSION 00) ON PAGE 18. THE SALES REPRESENTATIVE RE-TRAINED THE STAFF ON HOW TO ATTACH THE STEREO ATTACHMENT TO THE BEAM SPLITTER. FURTHERMORE HE SUGGESTED THE CUSTOMER TO PURCHASE A ROTATABLE BEAM SPLITTER IN ORDER TO AVOID THE ASSEMBLY AND DISASSEMBLY WHEN SWITCHING FROM ONE SIDE TO THE OTHER.

Description of Event or Problem

LEICA MICROSYSTEMS (B)(4) RECEIVED A COMPLAINT FROM FRANCE STATING THAT PRIOR TO SURGERY THE STEREO ATTACHMENT AND BINOCULAR TUBE FELL ONTO PATIENT'S FACE CAUSING A BROKEN NOSE AND A CUT BELOW THE EYE. THE SURGERY WAS NOT PERFORMED DUE TO SWELLING AND SHOCK.