VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 19, 2026 · Event occurred May 7, 2026
Report 9610773-2026-03842 · MDR key 25216834
Device
Product problems
- Loose or Intermittent Connection
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE RESOLUTION IS INADEQUATE. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE REPORTED EVENT OCCURRED DUE TO DAMAGE TO THE LLK (LASER LIGHT CABLE) PLUG OF THE VIDEO CABLE SECTION. ADDITIONALLY, THE INADEQUATE RESOLUTION IS LIKELY DUE TO A BROKEN R-UNIT (CHARGED COUPLED DEVICE). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
IT WAS REPORTED THAT THE LOCKING SPRING OF THE RIGID VIDEO LAPAROSCOPE PLUG WAS MISSING, CAUSING THE PLUG TO BECOME LOOSE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.