MalfunctionFSO
OPMI LUMERA 700
Received Feb 14, 2025 · Event occurred Jan 15, 2025
Report 9615010-2025-00002 · MDR key 21387786
Device
Generic name
Opmi Lumera 700
Manufacturer
Carl Zeiss Meditec Ag (jena) OkoProduct problems
- Unstable
- Detachment of Device or Device Component
- Unstable
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL CASE, A MECHANISM DETACHED DUE TO A LOOSE SCREW, CAUSING THE OPMI HEAD OF A LUMERA 700 TO HANG LOOSELY AT A 90 DEGREE ANGLE, ALMOST HITTING THE PATIENT IN THE FACE. THE USER MOVED THE PATIENT TO ANOTHER OPERATING ROOM AND COMPLETED THE CASE. THERE WAS NO INJURY OR NEGATIVE IMPACT TO A PATIENT, USER OR A THIRD PARTY.