ENDOGATOR 100126Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00677964058455), received between Oct 21, 2021 and Oct 21, 2021 — classified as 1 malfunction.

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

Recent adverse event reports

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

• MalfunctionOct 21, 2021Backflow; Backflow

  THE USER FACILITY REPORTED THAT POST-PROCEDURE, DURING THE PRE-CLEANING PROCESS, PROCEDURAL MATTER WAS OBSERVED TO BE FLOWING PAST THE MEDIVATORS ENDOGATOR BACKFLOW VALVE THROUGH THE IRRIGATION TUBING. THE REPORTED EVENT DID NOT OCCUR DURING A PATIENT PROCEDURE AND A PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT. ADDITIONALLY, NO HARM OR ADVERSE EVENT TO USER FACILITY PERSONNEL WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677615 ↗