MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 13, 2026
Report 9610773-2026-04901 · MDR key 25799136
Device
Product problems
- Erratic or Intermittent Display
- Connection Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF 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 THE CABLE WAS INTERNALLY DEFECTIVE AT THE CONNECTION POINT BETWEEN THE CAMERA AND THE CABLE, AND THAT THE IMAGE FLICKERED WHEN THE CABLE WAS TWISTED DURING INSPECTION FOR USE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.