MalfunctionODC
DEFENDO
Received Feb 13, 2026 · Event occurred Jan 15, 2026
Report 1528319-2026-00014 · MDR key 24337698
Device
Generic name
Suction Valve
Manufacturer
Us EndoscopyModel number
DEFENDO FUJIFILM 700 SERIESCatalog number
100325
Lot number
(10)13175349
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE SUBJECT OF THE REPORTED EVENT IS BEING RETURNED TO STERIS FOR EVALUATION. INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR DEFENDO SINGLE USE SUCTION VALVE BEGAN TO LEAK WATER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE. NO REPORT OF INJURY.