MalfunctionGCM
VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received Apr 28, 2026
Report 9610773-2026-03344 · MDR key 25018328
Device
Product problems
- Poor Quality Image
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 THAT THE RIGID VIDEO LAPAROSCOPE HAD SPOTS IN THE CENTER OF THE IMAGE. THE ISSUE WAS FOUND DURING THE INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.