MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Apr 30, 2026 · Event occurred Apr 22, 2026
Report 9610773-2026-03409 · MDR key 25048798
Device
Product problems
- No Display/Image
- Communication or Transmission Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE DISPLAYED ERROR 226 AND EXPERIENCED A BLACKOUT. THE ISSUE OCCURRED DURING SEDATION WHILE THE DEVICE WAS INSIDE THE PATIENT FOR A THERAPEUTIC LAPAROSCOPIC SACROCOLPOPEXY PROCEDURE. THERE WAS NO PATIENT HARM WAS 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.