Fusion G31905Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002319059), received between Dec 23, 2016 and Sep 29, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2023Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  DURING STONE REMOVAL FROM THE COMMON BILE DUCT, THE PHYSICIAN USED A COOK FUSION WIRE GUIDED EXTRACTION BASKET. IT WAS REPORTED THAT THE BASKET WOULD NOT RETRACT FULLY INSIDE THE DUCT. THE TIP OF THE BASKET BROKE OFF. THE DEVICE WAS REMOVED AND A FORCEP WAS USED TO REMOVE THE BROKEN PORTION OF THE BASKET. BASED ON INFORMATION RECEIVED FROM THE REP ON 09/26/2023 STATING THAT THE BASKET TIP WOULD NOT BREAK SO IT WOULD NOT RETRACT, WE ARE INTERPRETING THIS TO MEAN THAT THE BASKET BECAME IMPACTED WITH THE STONE AND THEY USED THE FORCEPS TO PULL THE WIRES OFF THE STONE TO ALLOW BASKET REMOVAL FROM THE PATIENT. 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 17842110 ↗
• MalfunctionNov 8, 2021Material Rupture; Material Rupture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION WIRE GUIDED EXTRACTION BASKET. IT WAS REPORTED THAT THE PROXIMAL END OF THE CATHETER WIRE BROKE OUTSIDE THE CATHETER. IT WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THIS DEVICE WAS RETURNED ON (B)(6) 2021 WITH THE BASKET EXTENDED AND DAMAGED. THE BASKET CABLE IS RUPTURED THROUGH THE SHEATH AT THE PROXIMAL END [SUBJECT OF REPORT]. THE BASKET COULD NOT BE RETRACTED DUE TO THE CABLE BEING RUPTURED THROUGH THE SHEATH. 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 12770367 ↗
• InjuryMay 5, 2017Break; Break

  THE FOLLOWING WAS REPORTED TO COOK: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION WIRE GUIDED EXTRACTION BASKET. WHILE ATTEMPTING TO PULL THE BASKET OUT, THE BASKET WIRE BROKE AND THE BASKET BECAME STUCK INSIDE THE PATIENT'S DUCT. THE PATIENT WENT TO THE OPERATING ROOM FOR AN OPEN CHOLECYSTECTOMY TO HAVE THE BASKET REMOVED. PER THE USER MEDWATCH (B)(4) RECEIVED FROM THE FDA ON 04/27/2017: "DOCTOR INSERTED EXTRACTION BASKET INTO DUCT DURING ERCP (ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY). WHILE ATTEMPTING TO PULL THE BASKET OUT THE WIRE BROKE AND BASKET BECAME STUCK IN DUCT."

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6547246 ↗
• MalfunctionDec 23, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. IT WAS REPORTED TO CUSTOMER RELATIONS THAT, "WE HAD PROBLEMS GETTING THE SPHINCTEROTOME THROUGH THE WIRE LOCK AND WHEN WE DID, THE SPHINCTEROTOME EXITED THE ENDOSCOPE WITH POOR ORIENTATION [INCORRECT CUTTING WIRE ORIENTATION]."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6202463 ↗