DEFENDO Biopsy Valve Irrigator
Received Jul 27, 2026 · Event occurred Jun 23, 2026
Report 1651395-2026-00013 · MDR key 50005846
Device
Generic name
Irrigator
Manufacturer
Medivators Inc.Model number
100303Catalog number
100303
Lot number
(10)660373
Product problems
- Leak/Splash
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The user facility reported that during a patient procedure their DEFENDO Biopsy Valve was leaking water. The procedure was completed successfully. No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation. Without the return of the device, an exact cause could not be determined. The Device History Record was reviewed and confirmed the lot subject of the event was manufactured to specifications; no abnormalities were noted. This is an isolated event for the subject lot. No additional issues have been reported.