Protocol Colon Insufflator 390301Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815112020122), received between Apr 15, 2022 and Apr 15, 2022 — classified as 1 injury.

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.

• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL AS AN INVALID REPORT DUE TO LACK OF PATIENT IDENTIFIERS ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER ON 29-MAR-2022 AND 31-MAR-2022. WITH THE RECEIPT OF ADDITIONAL INFORMATION, INCLUDING PATIENT IDENTIFIERS THIS CASE BECAME VALID, ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THE CASE DESCRIBES THE OCCURRENCE OF POSSIBLE CAECUM PERFORATION AND DISCOMFORT ABDOMINAL IN A (B)(6) OUTPATIENT MALE WHO UNDERWENT A VIRTUAL COLONOSCOPY WITH PROTOCOL 6400 COLON INSUFFLATOR ON (B)(6) 2022 DUE TO FAMILY HISTORY OF COLON CANCER. THE PATIENT'S MEDICAL HISTORY INCLUDED PRIOR VIRTUAL COLONOSCOPY 6 YEARS EARLIER, AND FAMILY HISTORY OF COLON CANCER. HE HAD AN UNSPECIFIED "MECHANICAL HEART VALVE" AND HE WAS TAKING WARFARIN FOR THIS REASON. NO OTHER MEDICAL HISTORY, INCLUDING ALLERGIES WAS PROVIDED. ON (B)(6) 2022, THE PATIENT UNDERWENT A VIRTUAL COLONOSCOPY WITHOUT SEDATION WITH PROTOCOL COLON INSUFFLATOR (MODEL NUMBER 6400, SERIAL NUMBER (B)(4)). THE LOT NUMBER IS UNKNOWN FOR THE PROTOCOL ADMINISTRATION SET IS UNKNOWN, THIS WAS DISCARDED. THE TECHNOLOGIST REPORTED THAT HE INFLATED THE PROTOCOL WITH 20 CC AIR THE

  Patient problems: Abdominal Pain; Bowel Perforation

  MAUDE report 14118074 ↗