Cotton Cannulatome II G49196Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002491960), received between Apr 8, 2016 and Nov 21, 2025 — classified as 1 injury, 2 malfunctions.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Material Separation; Material Separation

  DURING AN ENDOSCOPIC PROCEDURE IN THE DUODENUM AND BILE DUCT, THE PHYSICIAN USED A COOK COTTON CANNULATOME II PC PROTECTOR SPHINCTEROTOMES. IT WAS REPORTED THAT THE TIP OF THE CUTTING WIRE CAME UNDONE. [CUTTING WIRE SECURING COMPONENT SEPARATES FROM CATHETE-SUBJECT OF REPORT]. THE PAPILLA WAS LOCATED IN A DIVERTICULUM AND WAS ACTUALLY PROBED BLINDLY. AFTER UNSUCCESSFUL VISUALIZATION, THE PAPILLOTOME WAS REMOVED AND IT TURNED OUT THAT THE CUTTING WIRE HAD COME LOOSE. THE EXAMINATION WAS TERMINATED AND WILL THEN BE PERFORMED VIA PTCD [PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE]. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23619659 ↗
• MalfunctionJul 3, 2024Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK COTTON CANNULATOME II PC PROTECTOR. IT WAS INITIALLY REPORTED THAT THE PHYSICIAN TOOK THE DEVICE AND A COMPETITOR'S WIRE GUIDE TO GET ACCESS TO DUODENAL PAPILLA, THEN WHEN THE PHYSICIAN WAS READY TO CUT THE DUODENAL PAPILLA TOWARD THE COMMON BILE DUCT DIRECTION, THE ORIENTATION OF CUTTING WIRE WAS DEVIATED TO PANCREAS DUCT DIRECTION, USER REPEATEDLY PULLING THE CUTTING WIRE WHILE THE CUTTING WIRE BROKEN. THE PHYSICIAN CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER OUR PRODUCT EVALUATION ON 7 JUN 2024, IT WAS NOTED THAT THE CUTTING WIRE SECURING COMPONENT HAS SEPARATED FROM THE CATHETER WITHOUT DETACHMENT. [SUBJECT OF REPORT] 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19666427 ↗
• InjuryApr 8, 2016Break; Failure to Cut; Break; Failure to Cut

  ON (B)(6) 2016, THE FOLLOWING WAS REPORTED TO A COOK REPRESENTATIVE FROM THE USER FACILITY: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK COTTON CANNULATOME II PC PROTECTOR. THE CUTTING WIRE GOT TORN OFF AND DETACHED COMPLETELY FROM THE CATHETER. LATER, THE CUTTING WIRE WAS REMOVED WITH FORCEPS FROM THE DUODENUM. ON (B)(6) 2016, THE FOLLOWING WAS REPORTED TO COOK VIA A [(B)(6)] USER REPORT: IT WAS PLANNED TO REMOVE GALL STONES FROM A FEMALE PATIENT. FOR THIS A CUTTING WIRE (PAPILLOTOME) BY COOK WAS USED AMONG OTHERS, IN CONNECTION WITH A HIGH FREQUENCY MACHINE BY ERBE. CUTTING WAS NOT POSSIBLE, ONLY COAGULATION DESPITE CUTTING MODUS. FURTHERMORE, THE CUTTING WIRE TORE. THE TORN OFF PIECE WAS UNABLE TO BE RETRIEVED, EVEN WITH A FOREIGN-BODY FORCEPS; IT COULD NOT BE LOCATED. UPON REPLACEMENT OF THE CUTTING WIRE, NORMAL PAPILLOTOMY OF THE BILE DUCT SPHINCTER WAS POSSIBLE. PHOTOS OF THE TORN OFF CUTTING WIRE AND THE DEFECTIVE CUTTING WIRE ITSELF ARE WITH ME IN THE MEDICAL TECHNOLOGY DEPARTMENT. WE WILL NOTIFY COOK. WE HAVE REQUESTED THE PHOTOS OF THE CUTTING WIRE FROM THE USER FACILITY, BUT THEY HAVE NOT YET BEEN RECEIVED. ON (B)(6) 2016, WE

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 5563590 ↗