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Endogator Kit 4005472Recalls & reported problems

Medivators Inc. · Endogator 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 PENTAX 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 40677964028135), received between Nov 16, 2022 and Nov 16, 2022 — 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.

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.

  • MalfunctionNov 16, 2022Leak/Splash; Leak/Splash

    THE USER FACILITY REPORTED THAT THE PINCH CLAMP FOR THEIR ENDO SMARTCAP TUBING IS NOT STAYING CLOSED ALLOWING WATER TO LEAK ONTO THE FLOOR. NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15805983 ↗

Other endoscopic irrigation/suction system devices

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.