VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 5, 2026
Report 9610773-2026-03511 · MDR key 25076508
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD A BLURRY IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, SINCE REPORTED FAILURE WAS NOT CONFIRMED. THE MOST PROBABLE CAUSE OF THE REPORTABLE MALFUNCTION IS NO PROBLEM DETECTED. 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
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.