MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 26, 2026
Report 9610773-2026-04073 · MDR key 25278150
Device
Product problems
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DATE OF EVENT IS UNKNOWN. A SUPPLEMENT REPORT WILL BE SUBMITTED IF PROVIDED. 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 EXHIBITED ERROR E483. THE ISSUE WAS FOUND DURING INSPECTION FOR USE OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.