MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 11, 2026 · Event occurred May 5, 2026
Report 9610773-2026-03673 · MDR key 25142701
Device
Product problems
- No Display/Image
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD NO PICTURE AND IT SHUT OFF BY ITSELF. THE ISSUE WAS FOUND DURING A SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.