VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jun 11, 2026
Report 9610773-2026-04391 · MDR key 25470389
Device
Product problems
- Image Orientation Incorrect
Patient
Not reported
- 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
THE CUSTOMER REPORTED THAT THE IMAGE WAS REVERSED DURING INSPECTION FOR USE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, D9, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: POOR IMAGE QUALITY A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, NO IMAGE OCCURRED DUE TO BROKEN A-UNIT OF THE CHARGED COUPLED DEVICE UNIT (R-UNIT). THE MOST PROBABLE CAUSE FOR THE MALFUNCTION IS TRACED TO COMPONENT FAILURE. THE MOST PROBABLE CAUSE FOR REVERSED IMAGE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE.