inforMED
MalfunctionFSO

KINEVO 900

Received Sep 19, 2023 · Event occurred Aug 25, 2023

Report 9615010-2023-00006 · MDR key 17775194

Device

Generic name

Surgical Microscope

Model number

KINEVO 900

Catalog number

6640

Lot number

N/A

Product problems

  • Poor Quality Image
  • Optical Problem
  • Poor Quality Image
  • Optical Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING NEUROSURGERY, THE KINEVO 900 MONITOR SCREEN FROZE. RESTART DID NOT FIX THE ISSUE. THERE WAS NO INJURY OR NEGATIVE IMPACT TO A PATIENT, USER OR A 3RD PARTY. FOLLOW-UP SURGERY HAD A DELAY OF 30 MINUTES AS THE DEVICE HAD TO BE MADE TO WORK AGAIN.