MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 15, 2026
Report 9610773-2026-04940 · MDR key 25825639
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. E1 INITIAL REPORTER ESTABLISHMENT NAME : (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 A HAZY IMAGE IN ONE DIRECTION OF THE FIELD OF VIEW DURING INSPECTION FOR USE, INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WERE NO REPORTS OF PATIENT INJURY.