MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jun 29, 2026 · Event occurred Jun 3, 2026
Report 9610773-2026-04665 · MDR key 25660841
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1 - (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 IMAGE WITH PITTED DOTS DURING INSPECTION FOR USE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.