MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jun 9, 2026 · Event occurred Jun 4, 2026
Report 9610773-2026-04346 · MDR key 25445611
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1 - INITIAL REPORTER ESTABLISHMENT NAME- (B)(6) HOSPITAL. E1 - ADDRESS 1- (B)(6). 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 WATER FOG IN THE CENTER OF THE IMAGE DISPLAYED DURING MAINTENANCE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THE INTENDED PROCEDURE WAS THERAPEUTIC LAPAROSCOPIC SURGERY. THERE WAS NO PATIENT INJURY REPORTED.