MalfunctionFEB
ENDOSCOPE REPROCESSOR
Received Jul 17, 2026 · Event occurred Jun 23, 2026
Report 9610595-2026-57746 · MDR key 25860896
Device
Product problems
- Device Reprocessing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE FIELD SERVICE ENGINEER REPORTED THE SURFACE OF THE CLEANING BASIN WAS VERY DIRTY WITH WHAT APPEARED TO BE MOLD GROWING. THIS EVENT OCCURRED DURING SERVICE AND MAINTENANCE INVOLVING AN OLYMPUS ENDOSCOPE REPROCESSOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE 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.