inforMED
MalfunctionFSO

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

Model number

KINEVO 900

Catalog 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].