MalfunctionFSO
OPMI PENTERO
Received Nov 21, 2017 · Event occurred Oct 23, 2017
Report 9615010-2017-00014 · MDR key 7050751
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
NACatalog number
302582-9901-000
Lot number
NA
Product problems
- Device Operates Differently Than Expected
- Optical Problem
- Device Operates Differently Than Expected
- Optical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE DURING A TUMOR RESECTION SURGERY THE ZOOM AND FOCUS FUNCTIONS OF THE OPMI PENTERO 900 STOPPED WORKING. THE FLUORESCENCE FUNCTION OF THE MICROSCOPE COULD NOT BE ACTIVATED AS WELL. TROUBLESHOOTING DID NOT RESOLVE THE REPORTED ISSUES. THERE ARE NO FURTHER DETAILS PROVIDED BY THE DOCTOR ABOUT THE SURGERY OR THE PATIENT OUTCOME.