DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-411Q-0320Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170041945), received between Jan 10, 2023 and Jan 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionJan 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CUSTOMER REPORTED TO OLYMPUS THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THIS DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME WAS DISLODGED INTO THE PATIENT. IT WAS NOT CONFIRMED WHERE IT WENT AND WAS NOT RETRIEVED FROM THE PATIENT OR THE SCOPE. AN XRAY WAS PERFORMED AFTER THE PROCEDURE AND THE PHYSICIAN CANNOT CONFIRM ANY NEEDLE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134154 ↗