inforMED
MalfunctionFSO

OPMI LUMERA 300

Received Aug 14, 2023 · Event occurred Jul 17, 2023

Report 3008564898-2023-00004 · MDR key 17546773

Device

Generic name

Microscope, Surgical, General & Plastic Surgery

Model number

300

Catalog number

000000-2098-818

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

Unknown

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

Narrative

Description of Event or Problem

A CUSTOMER FROM NEPAL REPORTED THAT ON (B)(6) 2023 THE SUSPENDED COMPONENTS OF THE SUSPENSION ARM FELL INTO THE SURGEON'S ARM WHILE MOVING THE MICROSCOPE. NO ONE WAS INJURED. CUSTOMER CAUGHT THE COMPONENTS.

Additional Manufacturer Narrative

ROOT CAUSE: THE RELATED SCREW WAS NOT ASSEMBLED IN THE ASSEMBLY PROCESS OF THE SUSPENSION ARM.