PENTERO 900
Received Jan 9, 2019 · Event occurred Oct 18, 2018
Report 8281817 · MDR key 8281817
Device
Generic name
Surgical Microscope
Manufacturer
ZeissProduct problems
- Application Program Freezes or Fails to Launch
Patient
53 YR
- Stroke/CVA
- Stroke/CVA
Narrative
Description of Event or Problem
DURING "THE PERFORMING" A RIGHT CRANIOTOMY FOR EVACUATION OF A HEMATOMA AND CLIPPING OF A RUPTURED ANEURYSM, AFTER APPLYING THE TEMPORARY CLIPS THE ZEISS MICROSCOPE FROZE AND FLASHED A GREEN ERROR THROUGH THE OCULARS. SCOPE WAS USING THE PRIMARY POSITION. STAFF SHUT OFF THE SCOPE AND REBOOTED IT. FAILED AGAIN. THIS CAUSED A DELAY ABOUT 15 MINS DURING WHICH "DUE TO" THE TEMPORARY CLIPS ON THE CAROTID AND ANTERIOR CEREBRAL ARTERY RESULTED IN A SIGNIFICANT STROKE. IT IS UNCLEAR IF THIS WAS A SURVIVABLE SITUATION FOR THE PT FROM THE BEGINNING, BUT THE FAILURE OF THE MICROSCOPE CAUSED SIGNIFICANT HARM.