VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Apr 20, 2026
Report 9610773-2026-03138 · MDR key 24926812
Device
Product problems
- Erratic or Intermittent Display
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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
IT WAS REPORTED THE RIGID VIDEO LAPAROSCOPE HAD THE IMAGE ON THE SYSTEM MONITOR SWITCHED OFF 3 TO 4 TIMES. THERE WERE NO REPORTS OF PATIENT HARM.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Additional Manufacturer Narrative
UPDATED FIELDS- D8, H2, H3, H6, H11. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. 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 FIBER BONDING IN THE OUTER TUBE AREA DISTAL END DAMAGED A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE CUSTOMER REPORTED ISSUE OCCURRED DUE TO BROKEN VIDEO CABLE. WHEREAS THE FIBER BONDING IN THE OUTER TUBE AREA DISTAL END WAS DAMAGED DUE TO A COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.