MalfunctionNWU
DEFENDO
Received May 6, 2026 · Event occurred Apr 9, 2026
Report 1528319-2026-00045 · MDR key 25096426
Device
Generic name
Biopsy Valve
Manufacturer
Us EndoscopyModel number
00711901Catalog number
00711901
Lot number
(10)13417476
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE BIOPSY VALVE INCLUDED WITHIN THE DEFENDO SINGLE USE VALVE KIT WAS LEAKING WATER. NO REPORT OF INJURY OR PROCEDURE DELAY.
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.