Cotton-Leung G21979Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002219793), received between May 16, 2017 and Aug 12, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  WHEN THE DOCTOR INSERTED STENT INTO CBD, STENT WAS NOT INSERTED. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. ERCP PRODUCT CABINET (SHADED AREA) *WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? OLYMPUS VISIGLIDE2 0.025¿ 450CM. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES. WAS THE DEVICE AT THE CENTER OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES. WERE PREVIOUS PROCEDURES I.E., SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? HE DID SPHINCTEROTOMY. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NO. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME PROCEDURE. WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? OLYMPUS TJF-260V 4.2MM. DOES YOUR MEDICAL FACILITY HAVE A SERVICE/MAINTENANCE SCHEDULE ASSOCIATED WITH ITS ENDOSCOPES? NO. *WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781451 ↗
• InjuryMay 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THEY USED TO PLACE STENT AFTER AT THE DISTAL OF THE COMMON BILE DUCT STRICTURE SITE. THEY WERE ABLE TO CONFIRM THE STENT MIGRATION IMMEDIATELY AFTER PLACEMENT OF THE STENT. SO THEY REMOVED MIGRATION STENT.

  Patient problems: No Code Available

  MAUDE report 6568451 ↗