inforMED
MalfunctionFSO

OPMI LUMERA 700

Received Jul 6, 2026 · Event occurred May 27, 2026

Report 9615010-2026-00008 · MDR key 25725356

Device

Generic name

Microscope, Surgical, General & Plastic Surgery

Model number

700

Catalog number

305953-9905-000

Product problems

  • Unexpected Shutdown

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT DURING EYE SURGERY ON A CHILD, THE LAMP OF THE OPMI LUMERA 700 SUDDENLY SHUT DOWN. THE EXACT TYPE OF EYE SURGERY IS NOT KNOWN. THE CUSTOMER CONTACTED THE LOCAL FIELD SERVICE ENGINEER, WHO ATTEMPTED TO TROUBLESHOOT THE ISSUE REMOTELY AND GUIDED THE RESPONSIBLE BIOMED BY PHONE. THEY TRIED SHUTTING DOWN THE SYSTEM AND RESTARTING IT, SWITCHING TO ANOTHER LAMP, AND CONNECTING TO LED ILLUMINATION; HOWEVER, NONE OF THESE MEASURES WERE SUCCESSFUL. AS A RESULT, THE SURGERY HAD TO BE INTERRUPTED, AND THE CHILD HAD TO BE BROUGHT OUT OF AMNESIA. THE EVENT TOOK PLACE IN SWEDEN.