OPMI PENTERO
Received Mar 16, 2018 · Event occurred Feb 16, 2018
Report 9615010-2018-00005 · MDR key 7347052
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
- Device Operates Differently Than Expected
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
AT THE START OF A LUMBAR DECOMPRESSION SURGERY, THE LIGHT FIELD DIAMETER OF THE PENTERO MICROSCOPE COULD NOT BE AUTOMATICALLY OR MANUALLY ADJUSTED TO AN APPROPRIATE SIZE. NO OTHER MICROSCOPE NOR THE SURGEON'S LOUPES WERE AVAILABLE. THE SURGEON WAS ABLE TO GET GOOD DECOMPRESSION ON THE SPINE, BUT COULD NOT SEE WELL ENOUGH TO CAUTERIZE A CUT BLOOD VESSEL. A HEMOSTATIC AGENT WAS USED TO STOP THE BLEEDING SUFFICIENTLY TO CLOSE THE CASE. THE USUAL 1 HOUR PROCEDURE LASTED 4.5 - 5 HOURS, DURING WHICH AN UNPLANNED URINARY CATHETERIZATION WAS PERFORMED. THE PATIENT WAS DISCHARGED WITH A WOUND DRAIN.