DISTAL HOOD DISTAL HOOD 11302 MAJ-1989Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170314391), received between May 11, 2022 and May 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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.

• MalfunctionMay 11, 2022Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE ENDOSCOPE WAS INCORRECTLY REPROCESSED, AS THE DISTAL HOOD (SUBJECT DEVICE) WAS NOT REMOVED DURING THE REPROCESSING OF THE ENDOSCOPE. THE DEVICE WAS SUBSEQUENTLY USED ON ONE PATIENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366494 ↗