VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 5, 2026
Report 9610773-2026-03515 · MDR key 25080589
Device
Product problems
- Break
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: REMOTE SWITCH FUNCTION WAS NOT WORKING AND A DENT IN THE OUTER TUBE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE WAS TRACED TO COMPONENT FAILURE. 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 RIGID VIDEO LAPAROSCOPE LENS MOVED. THERE WERE NO REPORTS OF PATIENT HARM.