ENDOGATOR 100242Recalls & reported problems

Medivators Inc. · ENDOGATOR Auxiliary Water Jet Connector for PENTAX GI Endoscopes · Class 2

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00677964058493), received between Nov 22, 2016 and Mar 15, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fluid/Blood Leak1
Leak/Splash1

Patient problems

Exposure to Body Fluids1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 15, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER LEAKED FROM THE PLUGS WHILE USING THEIR AUXILIARY WATER JET CONNECTOR. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18914258 ↗
Nov 22, 2016Fluid/Blood Leak; Fluid/Blood Leak
THE CASE STATES THAT A SINGLE USE AUXILIARY WATER JET CONNECTOR FOR PENTAX ENDOSCOPES WAS LEAKING AND SPRAYED THE PHYSICIAN PERFORMING THE PROCEDURE. THERE IS POTENTIAL FOR CROSS CONTAMINATION.
Patient problems: Exposure to Body Fluids
MAUDE report 6123023 ↗

Device details

UDI-DI	`00677964058493`
Brand	ENDOGATOR
Model	100242
Company	Medivators Inc.
Product code	OCX · Endoscopic Irrigation/Suction System
Class	Class 2
FDA submission	K033695, K092429, K220395
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 16, 2023

Device type (GMDN): Surgical irrigation tubing set, single-use

A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

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All Endoscopic Irrigation/Suction System devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.