MEDICAL CONTROL UNIT FOR ENDOSURGERY
Received Apr 30, 2026 · Event occurred Apr 17, 2026
Report 3002808148-2026-13988 · MDR key 25049346
Device
Product problems
- No Display/Image
- Communication or Transmission Problem
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 SYSTEM INTEGRATION TRANSMISSION WAS NOT POSSIBLE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE ADDITIONAL INFORMATION FROM THE CUSTOMER. UPDATED FIELDS: B5, H2, H6, H11. 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
ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER: THE SYSTEM INTEGRATION HAD A BLACK SCREEN.