inforMED
MalfunctionFSO

OPMI LUMERA 300

Received Jan 23, 2024 · Event occurred Dec 26, 2023

Report 3008564898-2024-00001 · MDR key 18567466

Device

Generic name

Microscope, Surgical, General & Plastic Surgery

Model number

300

Catalog number

000000-2098-818

Product problems

  • Component Missing
  • Component Missing

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE RELATED SCREW WAS NOT ASSEMBLED IN THE ASSEMBLY PROCESS OF THE SUSPENSION ARM AND THERE WAS NO RELATED INSPECTION ITEM.

Description of Event or Problem

ON 2023-12-26, DURING REPAIR OF THE DEVICE, A FIELD SERVICE ENGINEER (FSE) FOUND THAT A SCREW WAS MISSING FROM THE SUSPENSION ARM. FSE REPAIRED THE DEVICE WITH A NEW SCREW. THE DEVICE WAS REPAIRED AND MET ZEISS SPECIFICATIONS. THERE WAS NO INJURY TO A PATIENT OR THIRD PARTY.