LEICA M220 F12

Additional Manufacturer Narrative

THIS IS A FINAL REPORT. A ROOT CAUSE ANALYSIS WAS CONDUCTED ON THE ACTUAL PARALLELOGRAM. NO INDICATION OF THE ALLEGED FAILURE MODE COULD BE FOUND, NAMELY THAT THE M220 OPTICS CARRIER DETACHED FROM THE PARALLELOGRAM AND FELL DOWN. BASED ON THE INVESTIGATION RESULTS, IT CAN BE CONCLUDED THAT THE M220 OPTICS CARRIER WAS RELIABLY FIXED TO THE PARALLELOGRAM. NO PROBLEM COULD BE 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 NOVEMBER 2021, LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED FEEDBACK FROM A CUSTOMER IN (B)(6) STATING THAT THE M220 OPTICS CARRIER FELL DOWN IN THE YEAR 2020. THERE WAS NO PATIENT OR USER INJURY. THE DEFECT WAS NOT REPORTED TO LEICA MICROSYSTEMS WHEN THE ISSUE OCCURRED. NOTE: BECAUSE ONLY A TIMEFRAME (IN THE YEAR 2020) BUT NO EXACT DATE OF EVENT WAS PROVIDED BY THE CUSTOMER, THE FIRST DAY OF THE GIVEN TIMEFRAME (01.01.2020) IS STATED AS A PROXY FOR THE DATE OF EVENT.