Fusion G55815Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002558151), received between Apr 26, 2016 and Apr 5, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2022Sharp Edges; Sharp Edges

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. IT WAS INITIALLY REPORTED THAT UPON INSPECTION, THE TIP OF THE SPHINCTEROTOME WAS CRACKED. THEY SIMPLY OPENED ANOTHER DEVICE AND CONTINUED WITH THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE ON 3/8/2022 DETERMINED THAT THE DISTAL TIP OF THE CATHETER IS CRACKED, IT IS ALSO JAGGED AND A PIECE OF THE CATHETER IS PROTRUDING OUT [SUBJECT OF REPORT]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014224 ↗
• MalfunctionMar 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. IT WAS INITIALLY REPORTED THAT THIS TOME LEFT A FOREIGN BODY ON THE WIRE [GUIDE] AFTER IT WAS EXCHANGED OUT OF THE SYSTEM. A PIECE OF THE DEVICE WAS LEFT ON THE WIRE [GUIDE] AFTER IT WAS EXCHANGED OUT. THIS CAUSED US TO HAVE TO REMOVE THE WIRE [GUIDE] TO REMOVE THE FOREIGN BODY. PER ADDITIONAL INFORMATION RECEIVED ON 2/4/2022: THERE WAS A RING THAT WAS LEFT ON THE WIRE [METAL BAND DETACHES]. [SUBJECT OF REPORT]: THE METAL BAND DETACHED ON THE WIRE [GUIDE] AFTER IT WAS EXCHANGED OUT AND CAUSED THE PHYSICIAN TO HAVE TO REMOVE THE WIRE [GUIDE] TO REMOVE THE FOREIGN 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13661287 ↗
• MalfunctionApr 26, 2016Material Separation; Material Separation

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. DURING THE PROCEDURE, THE CUTTING WIRE SECURING COMPONENT (ANCHOR) SEPARATED FROM CATHETER. IT WAS REPORTED THAT THERE WAS NO SERIOUS COMPLICATION WITH THIS PROBLEM. THIS EVENT INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THIS PATIENT HAD PRE-EXISTING OBSTRUCTIVE JAUNDICE WITH COMMON BILE DUCT STONE. THIS PATIENT WAS REPORTED TO BE A (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5609714 ↗