FL400 FOR M530

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 (SCHWEIZ) AG RECEIVED A COMPLAINT FROM GERMANY ABOUT FL400 BEING UNAVAILABLE DURING SURGERY. NO PATIENT INJURIES WERE REPORTED.

Additional Manufacturer Narrative

THIS IS A FINAL REPORT. A LEICA FIELD SERVICE ENGINEER INSPECTED THE AFFECTED DEVICE ON-SITE. THE CUSTOMER'S FL400 LICENSE FOR AN ARVEO 8 SYSTEM EXPIRED AFTER 365 DAYS INSTEAD OF BEING PERMANENT. AN INTERNAL INVESTIGATION CONCLUDED THAT AN EXPIRED LICENSE CANNOT AFFECT ONGOING SURGERIES. THE FOLLOWING OBSERVATIONS WERE MADE: · EXPIRING LICENSES HAVE NOT ONLY A FIXED EXPIRATION DATE BUT ALSO AN EXPIRATION TIME. · IF THE SYSTEM IS STARTED ON THE DAY OF EXPIRATION AFTER THE EXPIRATION TIME HAS PASSED, THE LICENSE WILL NOT BE AVAILABLE (E.G. FL400 FUNCTION CANNOT BE ACTIVATED). · IF THE SYSTEM IS STARTED ON THE DAY OF EXPIRATION BEFORE THE EXPIRATION TIME, THE LICENSE IS AVAILABLE AND REMAINS VALID AS LONG AS THE SYSTEM IS POWERED ON. ADDITIONALLY, THE FL400 MODE IS NOT DEACTIVATED IF IT IS ACTIVE DURING THE EXPIRATION TIME. FURTHERMORE, THE FL400 MODE CAN BE ACTIVATED AND DEACTIVATED AS LONG AS THE SYSTEM REMAINS POWERED ON, EVEN IF THE LICENSE HAS EXPIRED IN THE MEANTIME. · AFTER THE EXPIRATION TIME AND THE SYSTEM IS RESTARTED, THE RESPECTIVE LICENSE IS DEACTIVATED AND IS NO LONGER AVAILABLE (E.G., THE FL400 FUNCTION CAN NO LONGER BE ACTIVATED). · IN THIS SPECIFIC CASE, IT IS CLEAR THAT THE LICENSE COULD NOT HAVE EXPIRED DURING THE SURGERY. IT MUST HAVE EXPIRED SINCE THE LAST USAGE. A REVIEW OF THE COMPLAINT STATISTICS DID NOT SHOW ANY SIMILAR OR IDENTICAL CASE. THE REPORTED INCIDENT IS CONSIDERED AN ISOLATED EVENT. COUNTERMEASURES ARE BEING IDENTIFIED AND IMPLEMENTED AS PART OF CAPA-HER-MD-25-003. THE CAUSE WAS HUMAN ERROR: A TEMPORARY LICENSE WAS ISSUED INSTEAD OF A PERMANENT ONE. A NEW PERMANENT LICENSE HAS BEEN INSTALLED. THE DEVICE IS FUNCTIONING ACCORDING TO SPECIFICATIONS.