LEAK TEST AIR TUBE MAJ-821Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170069451), received between Apr 26, 2023 and Apr 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Microbial Contamination of 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionApr 26, 2023Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED, THAT THE FACILITY CLINICAL ENGINEER SUSPECTED ,THAT THE DEVICE VENT METAL COULD NOT BE DISINFECTED AT A HIGH LEVEL WITH THE SCOPE REPROCESSOR (OER-3). WHEN THE CULTURE TEST WAS PERFORMED, BACTERIA WAS DETECTED. ACCORDING TO THE REPORT, SINCE IT WAS CONDUCTED MORE THAN A HALF YEAR AGO, THE DETAILED TYPE AND AMOUNT OF BACTERIA ARE UNKNOWN. THERE ARE NO REPORTS OF ANY CONTAMINATION OR ANY PATIENT INJURY OR PATIENT INFECTION TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. NO USER INJURY REPORTED. THIS REPORT IS FOR THE LEAK TEST AIR TUBE INVOLVED IN THE EVENT AND IS RELATED TO THE FOLLOWING REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (GIF-XZ1200 - GASTROINTESTINAL VIDEOSCOPE). REPORT WITH PATIENT IDENTIFIER (B)(6) (OER-3 - ENDOSCOPE REPROCESSOR).

  Patient problems: Insufficient Information

  MAUDE report 16817412 ↗