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AquaShield 00711553Recalls & reported problems

US Endoscopy · The AquaShield system CO2 – Fujifilm is to be used with an air or carbon dioxide (CO2) source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816765013335), received between Aug 24, 2017 and Aug 24, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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

  • Fluid/Blood Leak2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 24, 2017Fluid/Blood Leak

    THE AQUASHIELD SYSTEM CO2 - FUJINON IS INTENDED TO BE USED WITH AN AIR OR CARBON DIOXIDE (CO2) SOURCE FROM AN ENDOSCOPE WITH THE PURPOSE OF SUPPLYING STERILE WATER TO THE ENDOSCOPE DURING ENDOSCOPIC PROCEDURES. IT IS COMPATIBLE WITH U.S. COMMERCIALLY AVAILABLE STERILE WATER BOTTLES. THIS DEVICE IS INTENDED TO BE USED FOR NOT MORE THAN 24 HOURS. THE USER FACILITY REPORTED DURING A PROCEDURE THE CONNECTION BETWEEN THE AQUASHIELD SYSTEM CO2 AND THE ENDOSCOPE WAS LEAKING STERILE WATER. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR THE USER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6817403 ↗
  • MalfunctionAug 24, 2017Fluid/Blood Leak

    THE AQUASHIELD SYSTEM CO2 - FUJINON IS INTENDED TO BE USED WITH AN AIR OR CARBON DIOXIDE (CO2) SOURCE FROM AN ENDOSCOPE WITH THE PURPOSE OF SUPPLYING STERILE WATER TO THE ENDOSCOPE DURING ENDOSCOPIC PROCEDURES. IT IS COMPATIBLE WITH U.S. COMMERCIALLY AVAILABLE STERILE WATER BOTTLES. THIS DEVICE IS INTENDED TO BE USED FOR NOT MORE THAN 24 HOURS. THE USER FACILITY REPORTED DURING A PROCEDURE THE CONNECTION BETWEEN THE AQUASHIELD SYSTEM CO2 AND THE ENDOSCOPE WAS LEAKING STERILE WATER. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR THE USER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6817349 ↗

Other PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE devices

All PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.