MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 13, 2026
Report 9610773-2026-04894 · MDR key 25798945
Device
Product problems
- Poor Quality Image
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THERE WERE ISSUES WITH THE IMAGE QUALITY INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WERE NO REPORTS OF PATIENT INJURY.