MalfunctionEPT
ARVEO 8X
Received May 13, 2026 · Event occurred May 6, 2026
Report 3003974370-2026-00004 · MDR key 25160967
Device
Product problems
- Electrical /Electronic Property Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 PORTUGAL STATING THAT AN ARVEO 8X SHUT DOWN DURING SURGERY. THERE WAS NO PATIENT INJURY.