DEFENDO Defendo Fujifilm 700 Series (REF 100325)Recalls & reported problems
Medivators Inc. · Defendo for Fuji 700, 5-piece Single Use Valve Kit with Air Water, Suction, Biopsy Valve, Connector, Cleaning Adapter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995228903), received between Apr 4, 2025 and Jul 9, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Suction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25770951 ↗MalfunctionFeb 13, 2026Leak/Splash
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24337698 ↗MalfunctionApr 4, 2025Suction Problem; Suction Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEY WERE HAVING ISSUES WITH THE SUCTION BUTTON TO THEIR DEFENDO SINGLE USE VALVE KIT RESULTING IN A LOSS OF SPECIMENS. REPORT OF PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21778530 ↗
Other PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE devices
- OLYMPUS OFP-2 (ROW)Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope296 reports
- Olympus MAJ-1651Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope125 reports
- Olympus WB991046OLYMPUS Winter & Ibe GmbH · Pump, Air, Non-Manual, For Endoscope81 reports
- ERBEFLO CleverCap® 20325-239Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall24 reports
- OLYMPUS OFP-2 (US)Keymed (Medical & Industrial Equipment) Limited · Pump, Air, Non-Manual, For Endoscope1 recall22 reports
- ERBEFLO CleverCap® 20325-206Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall5 reports
- ERBEFLO CleverCap® 20325-248Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall3 reports
- ERBEFLO CleverCap® 20325-240Erbe Medical, LLC · Pump, Air, Non-Manual, For Endoscope1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page