MOUTHPIECE
Received Mar 17, 2026
Report 9610595-2026-21872 · MDR key 24618769
Device
Product problems
- Contamination /Decontamination Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE MOUTHPIECE HAD A WHITE LIQUID SEEPS OUT DURING STERILIZATION. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION: OLYMPUS PERFORMED REPRODUCTION OF THE EVENT BY PROPER CONDITIONS OF STERILIZATION. THE EVENT WAS NOT REPRODUCED. THERE WERE NO VISUAL ABNORMALITIES, EITHER. SINCE OLYMPUS EVALUATION STERILIZED THE SUBJECT DEVICE IN ACCORDANCE WITH INSTRUCTION FOR SUE (IFU), THE CAUSE OF THE EVENT WAS NOT SPECIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.