VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 14, 2026
Report 9610773-2026-04916 · MDR key 25812486
Device
Product problems
- Poor Quality Image
- Dent in Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBLEM CAUSE OF THE REPORTED ISSUE WHITE DOT ON IMAGE AND DENTS AND GOLD-PLATING PEELING ON DISTAL EDGE WAS DUE TO IS 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
THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, WHITE DOT ON IMAGE AND DENTS AND GOLD-PLATING PEELING ON DISTAL EDGE WERE OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE WHITE DOT ON IMAGE AND DENTS AND GOLD-PLATING PEELING ON DISTAL EDGE WAS DUE TO IS TRACED TO COMPONENT FAILURE.THERE WAS NO PATIENT INVOLVEMENT.