MalfunctionFSO

KINEVO 900

Received Nov 19, 2019 · Event occurred Aug 26, 2019

Report 9340666 · MDR key 9340666

Device

Generic name

Microscope, Surgical, General

Manufacturer

Carl Zeiss Meditec, Inc.

Product problems

Failure to Align

Patient

8030 DA

No Consequences Or Impact To Patient
No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DURING A LEFT TEMPORAL CRANIOTOMY FOR ARTERIOVENOUS MALFORMATION (AVM), THE NAVIGATION MACHINE AND THE MICROSCOPE FAILED TO SYNCHRONIZE TO ALLOW NAVIGATION FOR THE CASE. IT TOOK SEVERAL REBOOTS OF THE NAVIGATION MACHINE AND A CHANGE OUT OF THE MICROSCOPE TO SOLVE THE PROBLEM. PER THE OR MANAGER, VARIOUS ISSUES WITH THE NEW KINEVO MICROSCOPES AND NAVIGATION SYNCHRONIZATION HAVE BEEN IDENTIFIED AND ARE BEING RESOLVED AS THEY OCCUR. ZEISS, MEDTRONIC AND OUR BIOMED DEPARTMENT ARE INVOLVED WITH THESE ISSUES. THERE WAS NO HARM TO THE PATIENT.