OPMI PENTERO 800
Received Dec 26, 2017 · Event occurred Nov 15, 2017
Report 9615010-2017-00019 · MDR key 7146459
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
800Catalog number
302582-9903-000
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
THE DIFFERENT FACTORS THAT CAN INFLUENCE THE RISK OF BURN INJURIES ARE DESCRIBED IN DETAIL IN THE USER MANUAL (G-30-1458-EN, ISSUE 9.1). RECOMMENDATIONS FOR REDUCING THE RISK OF BURNS ARE ALSO INCLUDED.
Description of Event or Problem
THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A HEAD AND NECK CANCER PATIENT SUSTAINED A BURN AFTER A FLAP SURGERY IN WHICH THE OPMI PENTERO MICROSCOPE WAS USED. THE MICROSCOPE LIGHT INTENSITY SETTING WAS AT 87% AND THRESHOLD VALUE LIGHT WARNING WAS AT 81%. IN THE FIRST HALF HOUR OF THE THREE HOURS SURGERY, THE HCP RECOGNIZED THAT THE VEIN HAD DRIED ON THE PATIENT'S NECK . AN ABUNDANT IRRIGATION WAS PERFORMED WITH SERUM PHYSIOLOGY AS AN AFTER TREATMENT.