Channel 2233-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994840240), received between Sep 29, 2017 and Jun 24, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2019Break; Poor Quality Image; Break; Poor Quality Image

  IT WAS REPORTED THAT WHEN THE SCOPE WAS OPENED, IT WAS BENT AT ONE PART. WHEN IT WAS SET UP AND TRYING TO FOCUS, THE SCOPE WAS SHOWING A WEIRD IMAGE THAT MUST HAVE BEEN THE INSIDE OF THE CHANNEL SCOPE AND NOT ACTUALLY THE SUTURE PACKET THEY WERE TRYING TO FOCUS ON TO SET IT UP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729342 ↗
• MalfunctionDec 6, 2018Break; Break

  IT WAS REPORTED THAT THE ENDOSCOPE FAILED UPON USE. ONE END OF THE ENDOSCOPE WAS BURNT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8137996 ↗
• MalfunctionSep 29, 2017Break; Break

  IT WAS REPORTED THE GLASS ON THE NEUROENDOSCOPE CRACKED WHEN OPENED. THE PRODUCT WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6904186 ↗