ENDOGATOR Kit 100611Recalls & reported problems

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 00677964052439), received between Apr 2, 2026 and Apr 2, 2026 — 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.

MalfunctionApr 2, 2026Leak/Splash
THE USER FACILITY REPORTED THEIR ENDOGATOR TUBING WAS LEAKING WATER DURING A PATIENT PROCEDURE AND OBSERVED A "HOLE" IN THE TUBING. THE LEAK WAS QUICKLY CONTAINED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY USING AN ADDITIONAL ENDOGATOR TUBING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767564 ↗

Device details

UDI-DI	`00677964052439`
Brand	ENDOGATOR Kit
Model	100611
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	Apr 27, 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.

Other Endoscopic Irrigation/Suction System devices

OrcaPod™ SUV-628
Boston Scientific Corporation · endoscopic irrigation/suction system
79 reports
2-piece valve kit (Suction and Air/Water Valve) EN10229.2
GA Health Company Limited · Endoscopic Irrigation/Suction System
1 recall0 reports
ERBEFLO CleverCap® 20325-201
Erbe Medical, LLC · Endoscopic Irrigation/Suction System
1 recall0 reports
andorate® A/W Channel Cleaning Adapter + 4-piece Valve Kit GAR3846
GA Health Company Limited · Endoscopic Irrigation/Suction System
1 recall0 reports
Suction Valve EN10232
GA Health Company Limited · Endoscopic Irrigation/Suction System
1 recall0 reports
ERBEFLO CleverCap® 20325-203
Erbe Medical, LLC · Endoscopic Irrigation/Suction System
1 recall0 reports
BullDog® 1203-71
Diversatek Healthcare, Inc. · Endoscopic Irrigation/Suction System
1 recall0 reports
ERBEFLO® 2 20325-222
Erbe Medical, LLC · Endoscopic Irrigation/Suction System
1 recall0 reports

All Endoscopic Irrigation/Suction System devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page