ENDOSCOPE REPROCESSOR
Received Jul 17, 2026 · Event occurred Jun 24, 2026
Report 9610595-2026-57756 · MDR key 25861077
Device
Product problems
- Infusion or Flow Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS ASSESSED ONSITE BY AN OLYMPUS FIELD SERVICE ENGINEER (FSE). THE FSE PULLED DRAIN HOSE OUT AND TIE WRAPPED TO DRAIN GRATE, TO PREVENT A VACUUM EFFECT. THE FSE DID NOT NOTICE AN INCREASE IN LIQUID LEVEL IN THE DISINFECTANT TANK DURING OPERATION. 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.
Description of Event or Problem
THE FIELD SERVICE ENGINEER REPORTED THE DRAIN HOSE WAS FAR DOWN THE DRAINPIPE AND THIS MAY HAVE CAUSED A VACUUM EFFECT. THIS EVENT OCCURRED DURING REPROCESSING INVOLVING AN OLYMPUS REPROCESSOR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.