GAS/WATER VALVE
Received Feb 20, 2026
Report 9610595-2026-16275 · MDR key 24399370
Device
Product problems
- Microbial Contamination of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF THIRD-PARTY TESTING, THE DEVICE EVALUATION AND THE COMPLAINT INVESTIGATION. UPDATED FIELDS: H6, H11. CUSTOMER PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS. SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: ENTIRE BUTTON, CFU: 6.8, BACTERIAL IDENTIFICATION: CLEBSIELLA GENUS. DESPITE GOOD FAITH EFFORTS BEING MADE, ADDITIONAL INFORMATION WAS NOT ABLE TO BE OBTAINED. GROWTH OF MICROORGANISMS WERE REPORTED THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED, AND A ROOT CAUSE COULD NOT BE DETERMINED. 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.
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.