Cotton G21969Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002219694), received between Nov 15, 2018 and Nov 15, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionNov 15, 2018Use of Device Problem; Use of Device Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK COTTON CANNULATOME. THE SPHINCTEROTOME CUTTING WIRE BROKE AFTER TWO (2) ATTEMPTS TO BEND [BOW] IT TO PERFORM THE SPHINCTEROTOMY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 10-OCT-2018: WHILE TRYING TO BEND [BOW] THE SPHINCTEROTOME, THE CUTTING WIRE BROKE, AND THE TIP DID NOT BEND. BENDING [BOWING] WAS ATTEMPTED WHILE PREPARING FOR CUTTING OF THE PAPILLA OF VATER. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED ON 26-OCT-2018 AND THE EVALUATION DETERMINED THAT APPROXIMATELY 20 MM OF THE CUTTING WIRE WAS MISSING AND NOT RETURNED WITH THE DEVICE. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER, THE LOCATION OF THE MISSING SECTION DETECTED DURING OUR LABORATORY EVALUATION IS UNKNOWN. 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 8075747 ↗