MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 13, 2026 · Event occurred Apr 17, 2026
Report 9610773-2026-03730 · MDR key 25161444
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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
IT WAS REPORTED THE RIGID VIDEO LAPAROSCOPE ENDOEYE WAS BROKEN. THIS ISSUE OCCURRED DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.