IMAGE MANAGEMENT HUB
Received Dec 2, 2025 · Event occurred Nov 4, 2025
Report 3002808148-2025-23946 · MDR key 23701082
Device
Product problems
- Communication or Transmission Problem
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE IMAGE MANAGEMENT HUB DISPLAYED ERROR 0001 (COMMUNICATION ERROR) DURING A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTION TO THE INITIAL REPORT SUBMITTED. UPDATED FIELDS: H2, H6, H11. THIS REPORT WAS SENT IN ERROR AS ERROR 0001 APPEARED WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. 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 CUSTOMER.