VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received May 7, 2026 · Event occurred Apr 9, 2026
Report 9610773-2026-03597 · MDR key 25108843
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION ADDED: B3 DATE OF EVENT.
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: THE CHARGED COUPLED DEVICE WAS BROKEN, SCOPE COMMUNICATION ERROR 226 OCCURRED AND NO IMAGE WAS DISPLAYED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: CAUSE 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
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE DISPLAYED A SCREEN WITH POOR IMAGE QUALITY. THE ISSUE WAS IDENTIFIED DURING AN INSPECTION PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT HARM.