Fusion G48676Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002486768), received between Jul 14, 2016 and Feb 13, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2020Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE WIRE GUIDE, WHILE BEING STRIPPED [ZIP EXCHANGED] BY THE TECHNICIAN, WAS NOT PUT OUT OF THE SPHINCTEROTOME [DID NOT COME OUT]. THE WIRE WAS FRAYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FUSION OMNI-TOME. 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 9706563 ↗
• MalfunctionNov 12, 2019Peeled/Delaminated; Positioning Problem; Peeled/Delaminated; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE COATING OF THE WIRE GUIDE STRIPPED AND THE WIRE GUIDE GOT STUCK IN THE SPHINCTEROTOME. THERE WAS NO SPARE WIRE GUIDE. THE ENTIRE PRE-LOADED SPHINCTEROTOME WAS REPLACED AND THE OPERATION CONTINUED WITHOUT OTHER DIFFICULTY OR DELAY [LOST WIRE GUIDE ACCESS] [SUBJECT OF THIS 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 Consequences Or Impact To Patient

  MAUDE report 9312623 ↗
• MalfunctionSep 30, 2019Positioning Problem; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE USER CANNULATED THE PANCREATIC DUCT AND TRIED TO DO AN EXCHANGE, BUT THE WIRE FRAYED SOMEWHERE IN THE MIDDLE OF THE DEVICE. THEY CHANGED TO ANOTHER MANUFACTURER'S SPHINCTEROTOME AND WIRE GUIDE [LOST WIRE GUIDE ACCESS, SUBJECT OF THIS 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 Consequences Or Impact To Patient

  MAUDE report 9136498 ↗
• MalfunctionJun 28, 2019Positioning Problem; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. DURING USE, THEY NOTICED THAT ON THE WIRE GUIDE THAT COMES PRELOADED WITH THE DEVICE, THE COATING ON THE WIRE BEGAN TO PEEL OFF AT THE DISTAL END OF THE WIRE. THE CUSTOMER CALLED IN "FRAYING" BUT THE COOK DISTRICT MANAGER BELIEVES IT WAS THE COATING PEELING. [THE USER] REMOVED THE DEVICE FROM THE PATIENT AND USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE [LOST WIRE GUIDE ACCESS AND SUBJECT OF THIS REPORT]. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019: THE USER CANNULATED THE BILE DUCT, INJECTED CONTRAST, PERFORMED A SPHINCTEROTOMY, AND REMOVED THE DEVICE [SPHINCTEROTOME] FROM THE ENDOSCOPE. AFTER THE DEVICE WAS REMOVED AND BEFORE THE NEXT DEVICE WAS ADVANCED OVER THE PRE-LOADED WIRE GUIDE THAT REMAINED IN THE DUCT, THEY NOTICED THE COATING OF THE WIRE COMING OFF AND REMOVED THE WIRE [LOST WIRE GUIDE ACCESS]. 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 EFFECT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744195 ↗
• MalfunctionSep 11, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: AT THE TIME, TO TRY TO CANNULATE, THE FIRST SPHINCTEROTOME HAD A BAD ORIENTATION [INCORRECT CUTTING WIRE ORIENTATION] (SUBJECT OF THIS REPORT). SO, THE ASSISTANT THREW IT AWAY AND OPENED A BRAND NEW TRI-25M-P [TRI-TOME PC PROTECTOR SPHINCTEROTOME] WHICH HAD THE SAME PROBLEM [INCORRECT CUTTING WIRE ORIENTATION] (SEE MDR 1307905-2018-00404). 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 7865149 ↗
• MalfunctionSep 4, 2018Material Separation; Material Separation

  THIS CORRECTION FOLLOW UP REPORT IS BEING SENT TO CANCEL THE INITIAL REPORT SUBMITTED RELATED TO THIS EVENT. PLEASE REFERENCE THE ADDITIONAL MANUFACTURER NARRATIVE FOR THIS JUSTIFICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7843604 ↗
• MalfunctionAug 20, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED THREE (3) COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOMES. UPON CANNULATING [ATTEMPTING TO], THEY USED THE DEVICE TO CANNULATE WITH THE WIRE GUIDE THAT WAS PROVIDED BUT COULD NOT CANNULATE, SO THEY REMOVED THAT WIRE GUIDE AND PUT IN ANOTHER MANUFACTURER'S WIRE GUIDE. THEY WERE ABLE TO CANNULATE, BUT OTHER MANUFACTURER'S WIRE GUIDE WAS TOO FLOPPY, SO IT WAS TAKEN OUT [OF THE SPHINCTEROTOME] AND THE COOK WIRE GUIDE THAT COMES WITH IT [THE PRE-LOADED WIRE GUIDE] WAS REUSED. THEY GOT "WHERE THEY NEEDED TO GO," BUT WHEN THE DOCTOR WENT TO REMOVE [THE SPHINCTEROTOME], THE SPHINCTEROTOME CAUGHT THE WIRE GUIDE AND THE WIRE GUIDE WOULD NOT COME BACK OR GO FORWARD [DIFFICULT EXCHANGE]. IT WAS STUCK IN PLACE. AT THAT POINT, THEY ATTEMPTED TO WIGGLE [THE DEVICE], AND THERE WAS NO PROGRESS. THE WIRE GUIDE KEPT SHREDDING (OUTER COAT) AS FORCE APPLIED FORWARD OR BACKWARDS [COATING DAMAGE]. THE ENTIRE DEVICE HAD TO BE PULLED OUT, AND IT LOST THE PHYSICIAN'S CANNULATION [LOST WIRE GUIDE ACCESS, SUBJECT OF THIS REPORT]. THIS WAS THE FIRST DEVICE. THEY ATTEMPTED TO USE ANOTHER OMNI-TOME. IT WAS A SIMILAR SITUATION, B

  Patient problems: Edema; No Consequences Or Impact To Patient

  MAUDE report 7799087 ↗
• MalfunctionJul 15, 2016Material Separation; Material Separation

  THIS REPORT SUMMARIZES "1" MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. DURING THE PROCEDURE, THE USER EXPERIENCED THE CUTTING WIRE SECURING COMPONENT (ANCHOR) SEPARATING FROM THE CATHETER. AFTER THE DEVICE WAS REMOVED FROM THE ENDOSCOPE, THE ANCHOR OF THE CUTTING WIRE BROKE OFF [ANCHOR DETACHED OUTSIDE OF THE PATIENT AND ENDOSCOPE]. THIS EVENT INVOLVED ONE (1) PATIENT WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5798598 ↗
• MalfunctionJul 14, 2016Peeled/Delaminated; Peeled/Delaminated

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT AN DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. DURING THE PROCEDURE, THE USER EXPERIENCED DAMAGE TO THE COATING OF THE PRE-LOADED WIRE GUIDE. THIS REPORT WAS DETERMINED (B)(6) 2016, WHEN THE COATING DAMAGE WAS FOUND DURING COOK ENDOSCOPY'S EVALUATION. THIS EVENT INVOLVED ONE (1) PATIENT WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5796281 ↗