OPMI PENTERO
Received Jun 30, 2023 · Event occurred Jun 5, 2023
Report 9615010-2023-00002 · MDR key 17239901
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
000000-0480-801Product problems
- Optical Problem
- Optical Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE INSTRUCTION FOR USE (IFU) CLEARLY STATES THAT THE USER SHOULD TAKE ADEQUATE PRECAUTIONS, DEPENDING ON THE APPLICATION, TO ENABLE THE SURGICAL PROCEDURE OR TREATMENT TO BE FINISHED WITHOUT USING THE DEVICE IN CASE OF MALFUNCTION OR SYSTEM ERROR.
Description of Event or Problem
A HEALTH-CARE PROFESSIONAL (HCP) REPORTED THAT A LIGHT MODULE ERROR, AUTO FOCUS MODULE ERROR OCCURRED AND THAT THE LIGHT WILL NOT COME ON DURING SURGERY. CONSEQUENTLY, THE DOCTOR WAS UNABLE TO COMPLETE THE SURGERY DUE TO THE NON-FUNCTIONING MICROSCOPE. A SECOND SURGERY FOR THE PATIENT WAS NECESSARY WHICH REQUIRED ADDITIONAL MEDICAL INTERVENTION.