Cook G13816Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002138162), received between Jul 19, 2019 and Jul 19, 2019 — classified as 1 malfunction.

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

• MalfunctionJul 19, 2019Positioning Problem; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK STANDARD WIRE GUIDE (THSF-35-480). THE ERCP WAS PERFORMED TO TREAT A BILE DUCT STENOSIS. THE WIRE GUIDE WAS ADVANCED THROUGH ANOTHER MANUFACTURER'S ERCP CATHETER (FOR 0.035"), BUT THE THSF BECAME UNMOVABLE DURING THE ERCP. THEREFORE, THE THSF AND THE CATHETER WERE REMOVED TOGETHER FROM THE ENDOSCOPE [LOSS OF WIRE GUIDE ACCESS]. THEN, THE USER ATTEMPTED TO PULL OUT THE THSF FROM THE CATHETER BUT THE THSF GOT UNRAVELED DURING THE ATTEMPT. A COMPETITOR'S WIRE GUIDE WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809157 ↗