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NA 00711556Recalls & reported problems

US Endoscopy · The Irrigation Kit CO2 Long includes 1 AquaShield System CO2 and 1 Torrent Irrigation Tubing · 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 00724995183912), received between Mar 19, 2021 and Mar 19, 2021 — classified as 1 malfunction.

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

Device problems

  • Defective Device1

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.

  • MalfunctionMar 19, 2021Defective Device

    STERIS ENDOSCOPY RECEIVED USER FACILITY MEDWATCH (B)(4) WHICH REPORTED THAT THE USER COULD NOT INSUFFLATE THE COLON WITH THREE 00711556 IRRIGATION KITS. THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER OF THE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11531441 ↗

Other Endoscope introducer kit devices

All Endoscope introducer kit devices →

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