VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received May 20, 2026 · Event occurred Oct 25, 2024
Report 9610773-2026-03900 · MDR key 25233925
Device
Product problems
- Material Split, Cut or Torn
- Sharp Edges
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION . A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE COMPLAINT 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 OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD CONTOUR SHARPNESS AT THE DISTAL END OF THE INSERTION SECTION, AND THE CHARGED COUPLED DEVICE (R-UNIT) WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT.