KINEVO® 900 6640Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049539066404), received between Aug 13, 2025 and Aug 13, 2025 — classified as 1 death.

The most frequently reported specific device problem is “Optical Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathAug 13, 2025Optical Problem; Optical Problem

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE OPMI KINEVO 900 STOPPED FOCUSING DURING A BRAIN OPERATION AFTER BLEEDING OF THE BRAIN HAD STARTED. IT WAS FURTHER REPORTED, THAT THE PATIENT LOST 7 LITERS OF BLOOD. THE DEVICE WAS WORKING WITHOUT ANY ISSUES UPON INSPECTION; NO FURTHER REPORTED ISSUES AFTER THE INCIDENT. THE SURGEON NOTED THAT THE BLEEDING OCCURRED BEFORE THE ASSUMED ISSUE WITH THE FOCUS. THE HEMORRHAGE WAS UNDER CONTROL BEFORE THE LOSS OF FOCUS AND RESTART OF THE DEVICE. NO HARM WAS REPORTED DIRECTLY FROM THE INCIDENT. THE DEVICE PROBLEM WAS RESOLVED BY SHUTTING DOWN AND RESTARTING THE MICROSCOPE. THE PATIENT DIED THREE DAYS AFTER SURGERY. THE REASON FOR THE DEATH REMAINS UNKNOWN TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22795061 ↗