AUXILIARY WATER TUBE MAJ-855 (REF N6175901)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170438004), received between Oct 7, 2024 and Oct 7, 2024 — classified as 2 malfunctions.

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

• MalfunctionOct 7, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE AUXILIARY WATER TUBE USED DURING THE SCOPE REPROCESSING PROCESS WAS WASHED IN THE SINK, BUT INSTEAD OF USING A HIGH-LEVEL DISINFECTANT, IT WAS SOAKED IN BLEACH AND THEN DRIED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385663 ↗
• MalfunctionOct 7, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE AUXILIARY WATER TUBE USED DURING THE SCOPE REPROCESSING PROCESS WAS WASHED IN THE SINK, BUT INSTEAD OF USING A RECOMMENDED HIGH-LEVEL DISINFECTANT FOR SUBSEQUENT DISINFECTION, IT WAS SOAKED IN BLEACH AND THEN DRIED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385583 ↗