LEICA M220 F12

Additional Manufacturer Narrative

THIS IS A FINAL REPORT. LEICA MICROSYSTEMS HAS PERFORMED A ROOT CAUSE INVESTIGATION WHICH REVEALED THAT THE FAILURE MODE IS RELATED TO A LOOSE SCREW IN THE SWING ARM OF THE LEICA M220 F12 WHICH IS HOLDING THE OPTICS CARRIER IN PLACE. THE DEVICE SHOWED, THAT THERE WAS INSUFFICIENT AMOUNT OF HIGH STRENGTH THREAD ADHESIVE APPLIED TO THE SCREW. THE IDENTIFIED ROOT CAUSE IS A WEAKNESS IN THE GLUING PROCESS INTENDED TO SECURE THE SCREW CONNECTING THE OPTICS CARRIER TO THE FREE END OF THE SWING ARM. ON 22 FEBRUARY, 2017 THE GLUING PROCESS AT THE SUPPLIER OF THE SWING ARM WAS CHANGED BY REDUCING THE AMOUNT OF HIGH STRENGTH THREAD ADHESIVE (WEICON AN302-70) APPLIED TO THE SCREW. WITH THE REDUCED AMOUNT OF HIGH STRENGTH THREAD ADHESIVE, A RELIABLE FIXATION OF THE SCREW CAN NO LONGER BE GUARANTEED. CONSEQUENTLY, IT IS POSSIBLE THAT THE SCREW CONNECTING THE OPTICS CARRIER TO THE FREE END OF THE SWING ARM WILL LOOSEN WHICH SUBSEQUENTLY CAN RESULT IN THE OPTICS CARRIER TO FALL. AN ENHANCEMENT OF THE DESIGN WAS INTRODUCED AND A FIELD SAFETY CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE ISSUE. FOR DETAILS REFER TO HEALTH HAZARD EVALUATION (B)(4).

Additional Manufacturer Narrative

AN INITIAL INVESTIGATION OF PROVIDED PICTURES AND A REPRESENTATIVE SAMPLE SHOWED, THAT THE FAILURE MODE IS RELATED TO A LOOSE SCREW WHICH IS HOLDING THE OPTICS CARRIER IN PLACE. FURTHER INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING INVESTIGATION.

Description of Event or Problem

LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM (B)(6) STATING THAT ON (B)(6) 2018 THE OPTICS CARRIER OF A LEICA M220 F12 FELL DOWN WHILE A NURSE REMOVED THE DUST COVER TO SET UP THE MICROSCOPE FOR SURGERY. SHE CAUGHT THE OPTICS CARRIER WITH HER HANDS BEFORE IT COULD HIT THE FLOOR. THERE WAS NO PATIENT / USER INJURY REPORTED. THE INCIDENT WAS REPORTED ON (B)(6) 2018.