VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 10, 2026
Report 9610773-2026-04857 · MDR key 25781321
Device
Product problems
- Corroded
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, IT IS LIKELY THE CAUSE OF THE CORROSION ON THE R-UNIT (CHARGED COUPLED DEVICE) TUBE WAS DUE TO COMPONENT FAILURE OF THE INSERTION TUBE. DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. 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
THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, CORROSION ON THE R-UNIT (CHARGED COUPLED DEVICE) TUBE WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.