ENDOGATOR Kit 100602Recalls & reported problems

Medivators Inc. · ENDOGATOR Kit contains the ENDOGATOR Irrigation Tubing for Boston Scientific ENDOSTAT II, Olympus OFP and ENDO STRATUS Irrigation Pumps and the ENDO SMARTCAP Rinse and Insufflation Tubing for certain Olympus GI Endoscopes · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00677964059636), received between Dec 14, 2023 and Dec 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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

Leak/Splash1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDO SMARTCAP TUBING PINCH CLIP IS NOT PINCHING THE TUBING CLOSED CAUSING WATER TO LEAK OUT. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18327952 ↗

Device details

UDI-DI	`00677964059636`
Brand	ENDOGATOR Kit
Model	100602
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	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 19, 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.