GAS/WATER VALVE
Received Feb 20, 2026
Report 9610595-2026-16272 · MDR key 24399181
Device
Product problems
- Microbial Contamination of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF THIRD-PARTY TESTING AND THE COMPLAINT INVESTIGATION. UPDATED FIELDS: H4, H6, H11. THE CUSTOMER PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS. SAMPLING DATE: (B)(6) 2026, SAMPLING FROM: ENTIRE BOTTOM, CFU: 75, BACTERIAL IDENTIFICATION: ESCHERICHIA COLI. SAMPLING DATE: (B)(6) 2026, SAMPLING FROM: ENTIRE BOTTOM, CFU: 15, BACTERIAL IDENTIFICATION: OTHER GUT BACTERIA. DESPITE GOOD FAITH EFFORTS BEING MADE, ADDITIONAL INFORMATION WAS NOT ABLE TO BE OBTAINED. BASED ON THE RESULTS OF THE INVESTIGATION, GROWTH OF MICROORGANISMS WAS REPORTED THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. THE REPORTED EVENT COULD NOT BE CONFIRMED, AND A ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Additional Manufacturer Narrative
THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE GAS/WATER VALVE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.