Fusion G31533Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002315334), received between Jun 6, 2016 and Feb 11, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Sharp Edges

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED TWO COOK FUSION TRIPLE LUMEN SPHINCTEROTOMES. IT WAS REPORTED THAT THE SPHINCTEROTOME WAS INTRODUCED AND THE PHYSICIAN FOUND THAT THE CATHETER DISTAL END WAS SPLIT. HE DECIDED TO USE A SECOND ONE WITH THE SAME LOT BUT IT WAS THE SAME PROBLEM. HE USED A THIRD ONE WITH ANOTHER LOT AND FINALLY IT WAS OK. 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 24313677 ↗
• MalfunctionJul 2, 2020Material Separation; Material Separation

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. THE CUTTING WIRE BROKE WHILE IN USE. THIS EVENT WAS NOT REPORTABLE AT THAT TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 04-JUN-2020 NOTING THE CUTTING WIRE CAME OFF IN THE PATIENT. THE CUTTING WIRE ELECTIVELY 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: Foreign Body In Patient

  MAUDE report 10227599 ↗
• MalfunctionDec 10, 2019Failure to Align; Malposition of Device; Failure to Align; Malposition of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) FUSION TRIPLE LUMEN SPHINCTEROTOME. THE ORIENTATION OF BOTH SPHINCTEROTOMES WERE INCORRECT DOWN THE ENDOSCOPE INTO THE SAME PATIENT. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9447771 ↗
• MalfunctionMar 21, 2019Material Separation; Material Separation

  DURING A SPHINCTEROTOMY, THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. WHEN THEY WENT TO PERFORM A SPHINCTEROTOMY, THE [CUTTING] WIRE AT THE TIP OF THE SPHINCTEROTOME SHATTERED AND BROKE OFF. THEY WERE UNABLE TO MAKE A CUT AND THEY HAD TO COME OUT, EXCHANGE THE EQUIPMENT AND START AGAIN. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 13-FEB-2019: THIS WAS A SPHINCTEROTOME COMPLAINT. THE [CUTTING] WIRE DID NOT FALL OFF AND IS STILL ATTACHED TO THE SPHINCTEROTOME. THE EQUIPMENT WAS EXCHANGED [WITH] A NEW WIRE GUIDE AND SPHINCTEROTOME. IT THEN WAS RELOADED INTO THE ENDOSCOPE, AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED ON 25-FEB-2019 AND THE EVALUATION DETERMINED THAT THE CUTTING WIRE SECURING COMPONENT HAD SEPARATED FROM THE CATHETER. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8439924 ↗
• MalfunctionOct 5, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. THE SPHINCTEROTOME WAS SET UP IN THE USUAL MANNER; HOWEVER, THE USER NOTED A TWIST IN THE DEVICE WHICH WAS CAUSING THE DEVICE TO ORIENT TOWARDS THE 9 O'CLOCK POSITION [INCORRECT CUTTING WIRE ORIENTATION]. A SECONDARY DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 7937882 ↗
• MalfunctionAug 20, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. THE ORIENTATION OF THE SPHINCTEROTOME WAS INCORRECT. 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 7797990 ↗
• InjuryDec 21, 2017Failure to Align; Failure to Align

  THE FOLLOWING WAS REPORTED TO THE FDA ON (B)(6) 2017: "DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. THERE WERE ORIENTATION PROBLEMS. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017: THE TIP IS NOT GOING IN THE DIRECTION AS IT IS SUPPOSED TO. THE CUTTING DIRECTION WAS 5/6 O'CLOCK [INCORRECT CUTTING WIRE ORIENTATION] THE SECOND PROBLEM WAS THAT CUTTING WIRE COULD NOT BE TENSED [UNABLE TO BOW], WHEN THE HYDROPHILIC WIRE PART WAS NOT IN THE AREA OF THE CUTTING WIRE (THE WIRE IS MORE RIGID IN THE PROXIMAL AREA). THE PATIENT EXPERIENCED ARTERIAL BLEEDING IN THE AREA OF THE PAPILLA AND INTERVENTION WAS REQUIRED. THE PHYSICIAN SUSPECTED THAT THE BLEEDING WAS CAUSED BY THE INCORRECT CUTTING WIRE DIRECTION. CLARIFICATION WAS RECEIVED ON 12/21/ 2017 THAT SURGICAL TREATMENT WAS REQUIRED." THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 12/28/2017: THE PATIENT REQUIRED SURGERY (SERGING [SEWING] THE GASTRODUODENAL ARTERY), AND RECEIVED T-DRAINAGE. AFTER THE SURGICAL CARE, THE PATIENT WAS YELLOW [JAUNDICED]. THE CAUSE WAS A COAGULUM [BLOOD CLOT]. AFTER REMOVING THE COAGULUM, THE PATIENT BLED AG

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hemostasis

  MAUDE report 7139601 ↗
• MalfunctionDec 21, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. THERE WAS AN ORIENTATION PROBLEM. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 11/30/2017: THERE WAS AN ORIENTATION PROBLEM RESULTING IN AN INABILITY TO CANNULATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138736 ↗
• MalfunctionDec 7, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A FUSION TRIPLE LUMEN SPHINCTEROTOME. WHEN THEY ADVANCED DOWN THE ENDOSCOPE, THE DISTAL END OF CATHETER CAME OUT OF THE DISTAL END OF THE ENDOSCOPE AT A 9'OCLOCK POSITION [INCORRECT CUTTING WIRE ORIENTATION]. THEY TRIED TO MANIPULATE TO MOVE THE DEVICE, BUT COULD NOT DO SO. THEY REMOVED THE DEVICE AND USED ANOTHER OF THE SAME TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7094922 ↗
• MalfunctionNov 2, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A FUSION TRIPLE LUMEN SPHINCTEROTOME. THE CUTTING WIRE SNAPPED DURING THE PROCEDURE [CUTTING WIRE BREAKS IN ONE LOCATION]. THE DEVICE WAS EVALUATED ON (B)(6) 2017 AND IT WAS OBSERVED THAT THE CUTTING WIRE SECURING COMPONENT DETACHED FROM THE CATHETER AND WAS NOT INCLUDED IN THE RETURN. THIS INFORMATION WAS COMMUNICATED TO THE USER FACILITY AND THE LOCATION OF THE MISSING SECTION IS UNKNOWN.

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

  MAUDE report 6996751 ↗
• MalfunctionApr 3, 2017Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: " IN THE SAME PROCEDURE, THE CUTTING WIRE DETACHED [CUTTING WIRE SECURING COMPONENT SEPARATED FROM CATHETER] FROM THE PROXIMAL END OF THE CATHETER AND WAS UNUSABLE. A THIRD DEVICE ALLOWED THEM TO COMPLETE THE PROCEDURE." [SEE RELATED MDR 1037905-2017-00142].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6453589 ↗
• MalfunctionNov 15, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. THE DEVICE WAS INSERTED DOWN THE ENDOSCOPE AND WHEN IT EXITED THE WORKING CHANNEL OF THE ENDOSCOPE, IT WAS AT A 2 O'CLOCK ANGLE RATHER THAN 11 O'CLOCK [INCORRECT CUTTING WIRE ORIENTATION]. THIS MADE CANNULATION OF THE BILE DUCT VERY DIFFICULT AND THEY USED ANOTHER MANUFACTURER'S DEVICE [TO COMPLETE THE PROCEDURE].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6102145 ↗
• MalfunctionOct 21, 2016Bent; Failure to Align; Bent; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. THE FOLLOWING WAS REPORTED TO THE SALES REPRESENTATIVE: THE "SPHINCTEROTOME WAS BENT AT DISTAL END. WHEN TRYING TO ENTER PAPILLA, IT WAS NOT POSSIBLE. I KNOW I TOOK SPECIAL CARE TO REMOVE THE METAL SAFETY POINT PROTECTOR [PRE-CURVED STYLET]. IT LOOKED QUESTIONABLE WHEN I TOOK IT OUT OF THE PACKAGE, BUT WE TRIED." THE DEVICE WAS REMOVED FROM THE ENDOSCOPE AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. CLARIFICATION WAS REQUESTED FROM THE COOK SALES REPRESENTATIVE AS TO WHETHER OR NOT THE CUSTOMER'S STATEMENT OF "BENT AT THE DISTAL END" MEANT THAT THE DEVICE HAD INCORRECT CUTTING WIRE ORIENTATION. THE COOK SALES REPRESENTATIVE RESPONDED WITH THE FOLLOWING COMMENT: "I DON'T BELIEVE SO. FROM WHAT THEY TOLD ME, THE END OF THE SPHINCTEROTOME WAS BENT. I'LL BE GATHERING MORE INFO FROM THE PHYSICIAN WHO HAD THE ISSUE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6048477 ↗
• MalfunctionSep 27, 2016Failure to Align; Failure to Align

  ON 08/23/2016, THE FOLLOWING WAS REPORTED TO COOK: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. "THERE IS A PRODUCT COMPLAINT WITH A SPHINCTEROTOME. NO FURTHER DETAILS GIVEN." ON 09/02/2016, WE RECEIVED THE FOLLOWING INFORMATION: "THE DEVICE WAS STRIPPED PRIOR TO THE PROCEDURE. ONCE THE DEVICE WAS INSERTED INTO THE ENDOSCOPE, THE DEVICE SHOWED PROBLEMS WITH ORIENTATION MAKING CANNULATION OF THE BILE DUCT VERY DIFFICULT [INCORRECT CUTTING WIRE ORIENTATION]."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5980457 ↗
• MalfunctionAug 11, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. THERE WAS POOR ORIENTATION. THE CANNULA [DISTAL TIP OF SPHINCTEROTOME] EXITED ENDOSCOPE BETWEEN THE 9-10 [O'CLOCK] POSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5868465 ↗
• MalfunctionJun 6, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME. THE PHYSICIAN REPORTED THAT THERE WAS POOR ORIENTATION. THE CANNULA WAS INTRODUCED AND EXITED THE WORKING CHANNEL OF THE ENDOSCOPE IN A 2 O'CLOCK POSITION, INCREASING THE DIFFICULTY OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5701710 ↗