MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 11, 2026 · Event occurred Apr 30, 2026
Report 9610773-2026-03679 · MDR key 25143344
Device
Product problems
- Dent in Material
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 A DENT IN THE CASING. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.