MalfunctionGCM
VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received Jul 1, 2026 · Event occurred Jun 22, 2026
Report 9610773-2026-04700 · MDR key 25679137
Device
Product problems
- Failure to Recalibrate
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED UNABLE TO PERFORM WHITE BALANCE DURING INSPECTION FOR USE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.