LEICA M220 F12

Additional Manufacturer Narrative

THIS IS A FINAL REPORT. LEICA MICROSYSTEMS CONDUCTED A ROOT CAUSE INVESTIGATION ON THE ACTUAL PARALLELOGRAM. THE PARALLELOGRAM SHOWED NO INDICATION FOR A MANUFACTURING DEFICIENCY. VISUAL INSPECTION REVEALED NO INDICATION FOR THE ALLEGED FAILURE MODE, NAMELY THAT THE M220 OPTICS CARRIER DETACHED FROM THE PARALLELOGRAM AND FELL DOWN. TESTING OF THE BREAK-AWAY TORQUE OF THE SCREW THAT CONNECTS THE OPTICS CARRIER TO THE SWING ARM SHOWED THAT THE SCREW WAS RELIABLY FIXED. MICROSCOPIC ANALYSIS CONFIRMED THAT THERE WAS A SUFFICIENT AMOUNT OF SECURING GLUE ON THE SCREW AND THE THREADS OF THE SCREW HOLE. RESULT OF THE IR SPECTROSCOPIC ANALYSIS RULED OUT THAT THE SCREW CONNECTION BETWEEN THE M220 OPTICS CARRIER AND THE PARALLELOGRAM HAD BEEN REWORKED OR MANIPULATED. BASED ON THE RESULTS OF THE INVESTIGATION, IT CAN BE CONCLUDED THAT THE M220 OPTICS CARRIER WAS RELIABLY FIXED TO THE PARALLELOGRAM AND DID NOT DETACH FROM THE PARALLELOGRAM. NO PROBLEM WAS DETECTED. NOTE: IT IS ASSUMED THAT THE COMPLAINT DESCRIPTION WAS RELATED TO INCORRECT BALANCING OF THE M220 F12 SYSTEM. IF THE M220 F12 IS NOT PROPERLY BALANCED, THE PARALLELOGRAM MAY MOVE DOWN ON ITS OWN. THIS MOVEMENT IS DETECTABLE PRIOR TO USE AS DESCRIBED IN THE INSTRUCTIONS FOR USE AND WILL NOT RESULT IN AN UNACCEPTABLE RISK TO THE PATIENT.

Additional Manufacturer Narrative

AN 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

FOLLOWING THE DISTRIBUTION OF THE FIELD SAFETY NOTICE FOR FSCA-CAPA-HER-MD-21-002 IN (B)(6) 2021, LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED FEEDBACK FROM A CUSTOMER IN (B)(6) STATING THAT THE M220 OPTICS CARRIER FELL DOWN IN OCTOBER 2021. THERE WAS NO PATIENT OR USER INJURY. THE DEFECT WAS NOT REPORTED TO LEICA MICROSYSTEMS WHEN THE ISSUE OCCURRED. NOTE: BECAUSE ONLY A TIMEFRAME ((B)(6) 2021) BUT NO EXACT DATE OF EVENT WAS PROVIDED BY THE CUSTOMER, THE FIRST DAY OF THE GIVEN TIMEFRAME (01.10.2021) IS STATED AS A PROXY FOR THE DATE OF EVENT.