Hydra SIT-361Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816849017525), received between Dec 20, 2019 and Jul 24, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Leak/Splash; Reflux within Device; Use of Device Problem; Leak/Splash; Reflux within Device; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA OLYMPUS WATER JET CONNECTOR WAS USED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE PERFORMED FOR THE TREATMENT OF ESOPHAGEAL VARICES ON (B)(6) 2025. DURING THE PROCEDURE WHILE LIGATING THE ESOPHAGEAL VARICES, A LEAK WAS NOTICED ACROSS THE ENDOSCOPE LENS WHILE APPLYING SUCTION. AT THE END OF THE PROCEDURE, IT WAS FOUND OUT THAT THE CONTAMINATED FLUID HAD RUN THROUGH THE HYDRA OLYMPUS WATER JET CONNECTOR AND ENTERED THE JET WASHER TUBING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FULLY RECOVERED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586342 ↗
• MalfunctionDec 20, 2019Defective Device; Defective Device

  NOTE: THIS REPORT PERTAINS TO TWO OF TWO DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING AND A WATER JET CONNECTOR WAS USED IN A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6)2019. ACCORDING TO THE COMPLAINANT, WHILE HYDRA IRRIGATION TUBING WAS CONNECTED TO A HYDRA WATER JET CONNECTOR, BACKFLOW OF LIQUID WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING ANOTHER HYDRA IRRIGATION TUBING AND WATER JET CONNECTOR. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9506137 ↗