MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 6, 2026
Report 9610773-2026-04757 · MDR key 25728262
Device
Product problems
- Image Display Error/Artifact
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE AVAILABLE. 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
THE CUSTOMER REPORTED DEVICE NONFUNCTIONAL AND ERROR CODE DURING A REPROCESSING PROCEDURE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.