MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 10, 2026
Report 9610773-2026-04856 · MDR key 25781214
Device
Product problems
- 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 THAT COMMUNICATION ERRORS 238 (SCOPE COMMUNICATION ERROR) AND 380 (ENDOSCOPE NOT CONNECTED) OCCURRED DURING PREPARATION FOR USE, INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.