Cannulatome II G25801Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002258013), received between Jan 10, 2019 and Apr 5, 2022 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2022Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME. IT WAS INITIALLY REPORTED THAT DURING ERCP THE CUTTING WIRE OF THE PAPILLOTOME SNAPPED. THE CUTTING WIRE TORE APART AFTER BEING TENSED TWO TIMES. IT WAS ADDITIONALLY REPORTED THAT THE WIRE POINTED 90 DEGREES UPWARDS AND THE DOCTOR HAD PROBLEMS TO PULL THE CT OUT OF THE DUCT. SHE FINALLY MANAGED TO REMOVE IT AND NOTHING STAYED INSIDE [THE PATIENT]. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER COMMUNICATION RECEIVED ON 08 MARCH 2022: CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF DEVICE AND DETACHED. IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER, FURTHER INFORMATION INDICATES THAT A PORTION DETACHED. 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014243 ↗
• MalfunctionJan 10, 2019Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK CANNULATOME II PC DOUBLE LUMEN SPHINCTEROTOME. THE CUTTING TOOL [WIRE] ON THE PRODUCT BROKE OFF. WHEN TRYING TO CUT WITH THE CUTTING WIRE, THE PHYSICIAN FELT THAT IT DID NOT CUT. A FEW SECONDS LATER SHE REALIZED THAT THE DISTAL END OF THE CUTTING WIRE CAME LOOSE. SHE HAD THE TIP FLEXED VERY MUCH. CLARIFICATION WAS RECEIVED ON (B)(6) 2018, STATING THAT THE CUTTING WIRE SECURING COMPONENT SEPARATED, BUT DID NOT DETACH. 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 8236809 ↗