MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jun 5, 2026 · Event occurred May 27, 2026
Report 9610773-2026-04288 · MDR key 25412341
Device
Product problems
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE LIGHT WAS NOT WORKING DURING SETUP INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.