DEFENDO SINGLE USE VALVE KIT 100322Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00677964092992), received between Jun 22, 2023 and Aug 14, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252557 ↗
• MalfunctionSep 5, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE BIOPSY VALVE TO THEIR DEFENDO SINGLE USE VALVE KIT LEAKED AND SPRAYED WATER ONTO USER FACILITY PERSONNEL. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977110 ↗
• MalfunctionMar 28, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE AUXILIARY ADAPTORS FROM THEIR DEFENDO SINGLE USE VALVE KIT HAVE BEEN LEAKING WATER OUT ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724990 ↗
• MalfunctionJan 9, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CONNECTION PORT BETWEEN THE ENDOSCOPE AND WATER JET PUMP HAD A "CRACK" SUBSEQUENTLY CAUSING WATER TO LEAK OUT ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117820 ↗
• MalfunctionFeb 15, 2024Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A VALVE WAS "STUCK" IN THE SCOPE AND COULD NOT BE ACTUATED. USER FACILITY PERSONNEL UTILIZED ANOTHER SCOPE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A PROCEDURE DELAY WAS REPORTED DUE TO EXCHANGE OF THE SCOPES. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18715005 ↗
• MalfunctionDec 21, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF THE DEFENDO - OLYMPUS VALVE KIT, THE AIR/WATER VALVE BECOMES "JAMMED" AFTER REPEATED ACTUATIONS CAUSING WATER TO ESCAPE FROM THE ENDOSCOPE CONTROL HEAD. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374800 ↗
• MalfunctionDec 20, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF THE DEFENDO - OLYMPUS VALVE KIT, THE AIR/WATER VALVE BECOMES "JAMMED" AFTER REPEATED ACTUATIONS CAUSING WATER TO ESCAPE FROM THE ENDOSCOPE CONTROL HEAD. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369636 ↗
• MalfunctionJun 22, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VIA MEDWATCH MW5117588 THAT THE IRRIGATION ADAPTOR THAT CONNECTS THE IRRIGATION TUBING TO THE ENDOSCOPY TOWER LEAKS. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187920 ↗