ENDOGATOR 100241Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00677964058486), received between Jan 30, 2020 and Aug 27, 2026 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Crack

  The user facility reported that during a patient procedure the ENDOGATOR Auxiliary Water Jet Connector ¿cracked¿ subsequently causing water to leak onto the floor. Another device was utilized and the procedure was completed successfully following a short delay. No report of injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479600 ↗
• MalfunctionApr 1, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VIA VIGILANCE REPORT TO ANSM THAT THEY HAD LEAKS WITH THEIR ENDOGATOR AUXILIARY WATER JET CONNECTOR. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015346 ↗
• MalfunctionFeb 23, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDOGATOR AUXILIARY WATER JET CONNECTOR WAS CAUSING WATER TO FLOW OUT OF THE SCOPE WHILE THE AIR WAS TURNED ON. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773839 ↗
• MalfunctionJan 30, 2020Break; Fluid/Blood Leak

  DURING NUMEROUS ENDOSCOPY'S, THE "ENDOGATOR SINGLE USE AUXILIARY WATER JET CONNECTOR" THAT WAS CONNECTED TO OLYMPUS GASTROENTEROLOGY ENDOSCOPES EITHER BROKE OFF COMPLETELY OR BEGAN TO LEAK WHILE THEY WERE USING THE WATER JET. I TALKED TO AMBULATORY CARE CENTER (ACC) NURSES, AND THEY SAID, BETWEEN THEIR UNIT AND THE OPERATING ROOM, OVER THE LAST 4 TO 6 WEEKS OR SO, THEY HAVE HAD ABOUT A DOZEN OF THE ENDOGATOR WATER JET CONNECTORS EITHER FAIL OR BREAK. WHEN THE CONNECTORS WOULD FAIL WITHOUT BREAKING OFF, THEY WOULD LEAK BETWEEN THE SMALL SEAL AND A CONNECTING PIECE OF PLASTIC, CAUSING LIMITED WATER TO BE USED IN THE CLEANING PROCESS DURING THE ENDOSCOPY. IF THE CONNECTOR COMPLETELY BROKE OFF, THE PROCEDURE WOULD NEED TO BE STOPPED UNTIL THE BROKEN PIECE COULD BE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9646658 ↗