ENDOGATOR hybrid irrigation tubing 100610Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00677964052361), received between Mar 31, 2023 and Dec 14, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDOGATOR HYBRID IRRIGATION TUBING UNCLAMPED CAUSING WATER TO LEAK OUT ONTO THE FLOOR. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332824 ↗
• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WATER LEAKED INTO THE ENDOSCOPE WHILE USING THEIR ENDOGATOR HYBRID IRRIGATION TUBING. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319678 ↗
• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WATER LEAKS FROM THE ENDOSCOPE WHILE USING THEIR ENDOGATOR HYBRID IRRIGATION TUBING. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319602 ↗
• MalfunctionApr 20, 2023Leak/Splash; Device Handling Problem; Leak/Splash; Device Handling Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, WHICH INCLUDED USE OF THE ENDOGATOR HYBRID TUBING AND ENDO STRATUS CO2 INSUFFLATOR, WATER LEAKED FROM THE ENDOSCOPE WHILE NEAR THE AIRWAY LEADING TO AN OXYGEN DROP. ADDITIONAL OXYGEN WAS GIVEN TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF PROCEDURE DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16781432 ↗
• MalfunctionMar 31, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDOGATOR HYBRID IRRIGATION TUBING UNCLAMPED DURING CLEAN UP BETWEEN CASES CAUSING WATER TO LEAK OUT ONTO THE FLOOR. AN EMPLOYEE SLIPPED AND FELL ON THE WATER AND OBTAINED A BRUISE. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED, AND THE EMPLOYEE CONTINUED WORKING.

  Patient problems: Bruise/Contusion

  MAUDE report 16654628 ↗