MalfunctionFSO
OPMI LUMERA 300
Received Dec 22, 2023 · Event occurred Dec 1, 2023
Report 3008564898-2023-00005 · MDR key 18384204
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Suzhou Co.,ltdModel number
300Catalog 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
ROOT CAUSE: THE MISSING SCREW WAS NOT ASSEMBLED DURING THE ASSEMBLY PROCESS OF THE SUSPENSION ARM.
Description of Event or Problem
DURING REPAIR OF THE OPMI LUMERA 300 DEVICE, A ZEISS FIELD SERVICE ENGINEER (FSE) FOUND THAT A SCREW WAS MISSING FROM THE SUSPENSION ARM AND THE YOKE CONNECTOR WAS STUCK ON THE SHAFT OF AXIS 4. THE FSE REPAIRED THE DEVICE BY REPLACING THE YOKE CONNECTOR AND PUT IN THE REQUIRED SCREW IN THE SUSPENSION ARM. THERE WAS NO INJURY TO A PATIENT OR THIRD PARTY.