LEICA M220 F12

Additional Manufacturer Narrative

THIS IS A FINAL REPORT. THE IDENTIFIED ROOT CAUSE FOR THIS ISSUE, THE M220 OPTICS CARRIER DROPPING DOWN, WAS IDENTIFIED AS HUMAN ERROR. THIS UNIT WAS PART OF A PREVIOUS FIELD SERVICE ACTION (FSCA CAPA-HER-MD-18-009). IT WAS DETERMINED THAT THE FSE WHO TESTED THIS UNIT FAILED TO FOLLOW THE INSTRUCTIONS AS REQUIRED BY FSCA CAPA-HER-MD-18-009 AND DID NOT PROPERLY TEST THE DEVICE. DURING THIS TEST, THE DEVICE WAS DETERMINED TO BE WITHIN SPECIFICATION, HOWEVER THIS DEVICE WAS ACTUALLY NON-CONFORMING. LEICA COMPLETED A MICROSCOPIC ANALYSIS OF THIS AFFECTED DEVICE BY AN INDEPENDENT TEST LABORATORY. THIS TEST DEMONSTRATED THAT THE DEVICE WOULD HAVE FAILED THE ACCEPTANCE CRITERIA OF 2NM BRAKE AWAY TORQUE SET IN CAPA-HER-MD-18-009, IF PROPERLY TESTED. BASED UPON THIS TEST, IT CAN BE CONCLUDED THAT IF THE FSE HAD FOLLOWED THE INSTRUCTIONS FOR FSCA CAPA-HER-MD-18-009, THE SWING ARM WOULD HAVE BEEN CORRECTLY IDENTIFIED AS NON-CONFORMING AND WOULD HAVE BEEN REPLACED PRIOR TO THE M220 OPTICS CARRIER DROPPING DOWN. BASED ON AN INTERVIEW WITH THE RESPONSIBLE SERVICE MANAGER AND A REVIEW OF THE COMPLAINT DATABANK, IT CAN BE CONCLUDED THAT THE COMPLAINT IS AN ISOLATED EVENT AND NO OTHER UNITS FROM THE PREVIOUS CAPA ARE AFFECTED. THE AFFECTED SWINGARM FOR THIS DEVICE WAS REPLACED PRIOR TO BEING RETURNED TO USE IN PATIENT CARE. NOTE: MANUFACTURER EVALUATION CONCLUSION CODE: THE CONCLUDED CAUSE IS NOT ADEQUATELY DESCRIBED BY ANY OTHER TERM. THEREFORE, WE SELECTED "APPROPRIATE TERM/CODE NOT AVAILABLE". THE IDENTIFIED ROOT CAUSE FOR THE M220 OPTICS CARRIER DROPPING DOWN IS A HUMAN ERROR. HOWEVER, IT CANNOT BE TRACED TO THE USER BUT TO THE FIELD SERVICE ENGINEER WHO FAILED TO FOLLOW THE INSTRUCTIONS.

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

LEICA MICROSYSTEMS (B)(4) AG RECEIVED A COMPLAINT FROM (B)(6) STATING THAT WHEN THE DOCTOR WAS TRYING TO ADJUST THE PARALLELOGRAM OF A M220 F12, THE OPTICS CARRIER FELL DOWN. THIS HAPPENED PRIOR TO SURGERY. THERE WAS NO PATIENT / USER INJURY REPORTED.