Fusion G31539Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002315396), received between Mar 12, 2019 and Jan 13, 2026 — classified as 3 malfunctions.

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

• MalfunctionJan 13, 2026Material Fragmentation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN NEEDLE KNIFE. IT WAS REPORTED THAT NEEDLE BROKE OFF AND WAS INSIDE THE PATIENT. THE NEEDLE PIECE WAS REMOVED WITH FORCEPS. THE DEVICE WAS RETURNED FOR EVALUATION, AND NO PORTION WAS DETACHED. IT IS UNKNOWN WHAT WAS RETRIEVED FROM THE PATIENT. A SECTION OF THIS DEVICE DID NOT REMAIN IN 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: Device Embedded In Tissue or Plaque

  MAUDE report 24053880 ↗
• MalfunctionJul 8, 2025Material Fragmentation; Material Fragmentation

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN NEEDLE KNIFE. IT WAS REPORTED THAT DURING USE, THE BLADE REMAINED IMPLANTED IN THE PATIENT, DETACHING FROM THE DEVICE. THE CUSTOMER OPENED THE PACKAGE AND TESTED THE DEVICE, ALL WAS GOOD. ONCE IN GOOD POSITION, IN FRONT OF THE PAPILLA WITHOUT TOO MUCH BENDING, THEY INSERTED THE DEVICE INTO THE SCOPE CHANNEL AND THE PHYSICIAN ASKED TO DEPLOY THE NEEDLE, THEY STARTED TO CUT THE PAPILLA, BUT THE NEEDLE BROKE AND STAYED IN THE PAPILLA. THEY REMOVED THE NEEDLE, TOOK ANOTHER SYSTEM AND THEY FINISHED EXAMINATION WITHOUT PROBLEM. IT WAS REPORTED THAT NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY, A PIECE OF THE NEEDLE DETACHED, BUT NO FURTHER INFORMATION WAS PROVIDED ON HOW IT WAS RETRIEVED. THE INITIAL REPORTER ALSO STATED THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES, AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22440276 ↗
• MalfunctionMar 12, 2019Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN NEEDLE KNIFE. DURING THE PROCEDURE, THE DEVICE BROKE OFF AND WENT INTO THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED BY THE COOK DISTRICT MANAGER ON 19-FEB-2019: AN ADDITIONAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE SECTION OF THE DEVICE WAS LEFT IN THE PATIENT. CLARIFICATION WAS RECEIVED ON 28-FEB-2019 AND INDICATED THAT THE CUSTOMER ATTEMPTED TO RETRIEVE THE BROKEN PORTION BUT, THAT THEY WERE UNSUCCESSFUL. THE PIECE OF THE BROKEN NEEDLE KNIFE REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. 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: Device Embedded In Tissue or Plaque

  MAUDE report 8413831 ↗