VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 9, 2026
Report 9610773-2026-04814 · MDR key 25758272
Device
Product problems
- Break
- Poor Quality Image
- Scratched Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. 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 FOLLOWING LED TO THE MALFUNCTION: THE COVER GLASS OF THE INSERTION SECTION WAS SCRATCHED; THEREFORE, THE IMAGE WAS POOR, THE MENISCUS OF THE CHARGED COUPLED DEVICE (R-UNIT) SECTION WAS BROKEN, THEREFORE THE IMAGE WAS POOR. 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 TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN IDENTIFIED SCRATCHES ON THE COVER GLASS OF THE INSERTION SECTION, A BROKEN MENISCUS IN THE CHARGED COUPLED DEVICE (R-UNIT) SECTION, AND POOR IMAGE QUALITY. THERE WAS NO PATIENT INVOLVEMENT.