CARL-ZEISS KINEVO
Received Jul 30, 2025 · Event occurred Jun 19, 2025
Report 22663559 · MDR key 22663559
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec AgModel number
KINEVO 900Catalog number
6640
Lot number
ECN LPCH59342
Product problems
- Computer Operating System Problem
- Unexpected Shutdown
Patient
11 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WHILE THE PATIENT IS UNDER ANESTHESIA AND SURGICAL SITE OPEN, THE MICROSCOPE TURNED OFF BY ITSELF AND DID NOT REBOOT APPROPRIATELY. BIOMED ENGINEERING AND OUR REP FROM MEDTRONIC TRIED TO TROUBLESHOOT IT BUT PATIENT WAS NOT OPERATED ON FOR 10 MINUTES DURING THIS TIME. IT FINALLY RESET AND WORKED, AND THE RESOURCE NURSE WAS INFORMED TO ASK FOR A BACKUP MICROSCOPE IN CASE IT STOPPED WORKING MID CASE AGAIN. THE VENDOR FOR THE MICROSCOPE HAS BEEN INFORMED AND WILL BE ARRIVING WEDNESDAY, [DATE REDACTED] AND WILL BE DOING THE REPAIRS. THE COMPANY TECHNICIAN CONDUCTED AND FULL ANALYSIS AND REPAIR OF THE MICROSCOPE. THE INTERGRATIONS OF THE MICROSCOPE AND NAVIGATION SOFTWARE WAS NOT WORKING PROPERLY. MANUFACTURER RESPONSE FOR MICROSCOPE, CARL-ZEISS (PER SITE REPORTER). THE COMPANY TECHNICIAN CONDUCTED AND FULL ANALYSIS AND REPAIR OF THE MICROSCOPE [DATE REDACTED].