KINEVO 900
Received Jan 5, 2024 · Event occurred Dec 13, 2023
Report 9615010-2023-00018 · MDR key 18451563
Device
Generic name
Kinevo 900
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Product problems
- Optical Problem
- Optical Problem
Patient
NA · Unknown
- Perforation of Vessels
- Perforation of Vessels
Narrative
Description of Event or Problem
THE SURGEON DAMAGED A CEREBRAL VESSEL DUE TO INADEQUATE LIGHTING. A BYPASS HAD TO BE SUTURED IN AN EMERGENCY. NO OTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
DESCRIPTION OF CHANGES: FIELD B4: ADDED "DATE OF THIS REPORT" 04/23/2024. FIELD G3: UPDATED "DATE RECEIVED BY MANUFACTURER" TO "04/19/2024". FIELD G6: CHECKED "30 DAYS", UPDATED TO "FOLLOW-UP, # 1". FIELD H2: CHECKED "DEVICE EVALUATION" FIELD H3: UPDATED "DEVICE EVALUATED BY MANUFACTURER?" TO "YES". FIELD H6: ADDED "TYPE OF INVESTIGATION" CODE 10, ADDED "INVESTIGATION FINDINGS" CODE 213, ADDED " INVESTIGATION CONCLUSION" CODE 67, AND CODE 4315. FIELD H11: ADDED DESCRIPTION OF CHANGES. FILE ATTACHMENTS: ATTACHED DEVICE EVALUATION.