ENDO STRATUS Irrigation Pump EGA-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00677964063664), received between Nov 6, 2019 and Sep 2, 2022 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2022Break; Break

  THE USER FACILITY REPORTED THAT THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349270 ↗
• MalfunctionAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT BLEEDING OF THE COLON HAS OCCURRED DURING TWO SEPARATE PATIENT PROCEDURES WHICH INCLUDED USE OF THE ENDO STRATUS IRRIGATION PUMP. NO ADDITIONAL TREATMENT WAS REQUIRED FOR THE PATIENTS AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY WITHOUT DELAY. THE PATIENTS WERE DISCHARGED.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 15298202 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THEIR ENDO STRATUS IRRIGATION PUMP WAS IRRIGATING HARDER THAN NORMAL DURING A PROCEDURE AND CAUSED A PATIENT TO BLEED.

  Patient problems: Abrasion

  MAUDE report 9288225 ↗