DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-401Q-0320Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170041587), received between Mar 17, 2023 and Mar 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Jan 7, 2026Class IIOpen, Classified

   Devices which did not undergo thermoforming could deform and lose performance.

   Z-1294-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Jan 7, 2026Class IIOpen, Classified

   Devices which did not undergo thermoforming could deform and lose performance.

   Z-1293-2026 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionMar 17, 2023Break; Break

  THE CUSTOMER REPORT TO OLYMPUS THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), IT WAS REPORTED THAT THE SPHINCTERTOME WIRE SNAPPED. THE PROCEDURE WAS EXTENDED AN ADDITIONAL TEN MINUTES TO LOCATE THE WIRE THAT WAS POSSIBLY LODGED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. NO ADDITIONAL TREATMENT WAS REQUIRED. THERE WAS NO REPORTED PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564309 ↗