ENDOGATOR hybrid irrigation tubing 100609Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00677964052354), received between Aug 15, 2018 and Feb 23, 2024 — classified as 1 injury, 7 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.

• MalfunctionFeb 23, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WATER LEAKED FROM THE TUBE CONNECTING TO CO2 CONNECTOR WHILE USING THEIR ENDOGATOR HYBRID IRRIGATION TUBING. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773840 ↗
• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319586 ↗
• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317386 ↗
• MalfunctionDec 12, 2023Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315108 ↗
• MalfunctionDec 8, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WATER LEAKS FROM THE ENDOSCOPE WHILE USING THEIR ENDOGATOR HYBRID IRRIGATION TUBING. THIS HAS OCCURRED DURING SET-UP AND PATIENT PROCEDURES. THE PROCEDURES WERE COMPLETED SUCCESFULLY. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291681 ↗
• MalfunctionJul 13, 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, STERILE WATER LEAKED FROM THE ENDOSCOPE OBSCURING THE PHYSICIAN'S FIELD OF VISION. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316600 ↗
• MalfunctionApr 12, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF THE ENDOGATOR HYBRID TUBING, STERILE WATER LEAKED FROM THE ENDOSCOPE. THE PATIENT DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725220 ↗
• InjuryAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ASPIRATED DURING AN UPPER GI ENDOSCOPY PROCEDURE USING AN OLYMPUS HQ190 ENDOSCOPE AND WAS HOSPITALIZED FOR ASPIRATION PNEUMONIA. MEDIVATORS ENDOGATOR HYBRID IRRIGATION TUBING WAS BEING USED DURING THE PROCEDURE AND THE FACILITY REPORTED THAT THE TUBING WAS LEAKING AND CAUSED THE PATIENT ADVERSE EVENT.

  Patient problems: Aspiration/Inhalation

  MAUDE report 7787005 ↗