ENDOGATOR 100130Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00677964058462), received between Sep 30, 2022 and Jan 3, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ENDOGATOR IRRIGATION TUBING WAS LEAKING WATER AT THE CONNECTION TO THE CO2 PUMP ONTO THE FLOOR. USER FACILITY PERSONNEL CHANGED THE TUBING RESULTING IN A SHORT PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21071855 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDOGATOR IRRIGATION TUBING WAS CRACKED AND LEAKING. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326415 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDOGATOR IRRIGATION TUBING WAS CRACKED AND LEAKING. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326361 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDOGATOR IRRIGATION TUBING WAS CRACKED AND LEAKING. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326252 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDOGATOR IRRIGATION TUBING WAS CRACKED AND LEAKING DURING A PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326009 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDOGATOR IRRIGATION TUBING CRACKED. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325780 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDOGATOR IRRIGATION TUBING CRACKED DURING A PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325671 ↗
• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CLAMP TO THEIR ENDOGATOR IRRIGATION TUBING WOULD NOT STAY CLAMPED AND LEAKED POST PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18323577 ↗
• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDOGATOR IRRIGATION TUBING CRACKED WITHIN THE ROLLER SECTION OF THE PUMP. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320532 ↗
• MalfunctionDec 15, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ENDOGATOR TUBING CRACKED SUBSEQUENTLY CAUSING WATER TO LEAK OUT ONTO THE FLOOR. THE TUBING WAS REPLACED SUBSEQUENTLY CAUSING A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987013 ↗
• MalfunctionNov 21, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES, THE ENDOGATOR IRRIGATION TUBING THAT ATTACHES TO THEIR ENDO STRATUS IRRIGATION PUMPS WAS CRACKING ALLOWING WATER TO LEAK ONTO THE FLOOR AND SUBSEQUENTLY CAUSING PROCEDURE DELAYS. USER FACILITY PERSONNEL REPLACED THE TUBING, CLEANED UP THE WATER, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15839719 ↗
• MalfunctionOct 12, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT TWO OF THEIR ENDOGATOR IRRIGATION TUBING SETS SPLIT AND LEAKED WATER ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592021 ↗
• MalfunctionSep 30, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDOGATOR TUBING IS BEING LACERATED IN THE PUMPS DURING PROCEDURES AND CAUSING WATER TO LEAK ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514903 ↗