Endogator Kit 4005470Recalls & reported problems

Medivators Inc. · Endagator Kit includes Endogator Irrigation Tubing, for Endogator EGP-100 Irrigation pump, Olympus OFP Pump, gi4000 ESU or Torrent Irrigation Pump. and ENDO SMARTCAP Rinse and Insufflation tubing for certain OLYMPUS 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 40677964027978), received between Dec 13, 2023 and May 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Break1
Leak/Splash1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

MalfunctionMay 29, 2025Break; Break
THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE THAT THEIR ENDOGATOR TUBING SET BROKE WHICH RESULTED IN A PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107999 ↗
MalfunctionDec 13, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THE CLAMP TO THEIR ENDO SMARTCAP TUBING CAME LOOSE. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320865 ↗

Device details

UDI-DI	`40677964027978`
Brand	Endogator Kit
Model	4005470
Company	Medivators Inc.
Product code	OCX · endoscopic irrigation/suction system
Class	Class 2
FDA submission	K102855
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 22, 2022

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