VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 15, 2026 · Event occurred Jun 22, 2026
Report 9610773-2026-04964 · MDR key 25830321
Device
Product problems
- Degraded
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN, INDICATES THAT A R-UNIT (CHARGED COUPLED DEVICE) WAS BROKEN AND THEREFORE THE RESOLUTION WAS INADEQUATE. THERE WAS NO PATIENT INVOLVEMENT.
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 FOLLOWING LED TO THE MALFUNCTION: THE RESOLUTION WAS INADEQUATE DUE TO BROKEN R UNIT (CHARGED COUPLED DEVICE) SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.