DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-401Q-0730Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170041709), received between Oct 8, 2020 and Jun 16, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 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-1289-2026 · Root cause: Process control · Recall details · FDA record ↗

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 16, 2022Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  AS REPORTED, DURING AN ENDOSCOPIC CHOLANGIO-PANCREATOGRAPHY THERAPEUTIC PROCEDURE, AT THE TIME OF THE SPHINCTEROTOMY OF THE ODDI SPHINCTER, THE WIRE IS CUT BY THE ELECTRIC ARC OF THE KNIFE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SPHINCTEROTOME (SIMILAR DEVICE) FROM THE SAME LOT WITHOUT ANY ISSUE. NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14710619 ↗
• MalfunctionMay 13, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM OLYMPUS (B)(4) THAT DURING SPHINCTEROTOMY PROCEDURE USING THE SUBJECT DEVICE, WHEN THE CUTTING KD WIRE BROKE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822988 ↗
• MalfunctionOct 8, 2020Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING A BILIARY PROCEDURE AND PAPILLA CUTTING, THE SUBJECT DEVICE WAS USED. THE CUTTING WIRE BROKE. ANOTHER DEVICE WAS THEN USED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. ON SEPTEMBER 16, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE CUTTING WIRE WAS BROKEN OFF, AND THAT THE BROKEN SECTION OF THE CUTTING WIRE WAS MELTED AND BURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10653557 ↗