Fusion G34711Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002347110), received between Jul 8, 2016 and May 20, 2021 — classified as 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2021Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. THE PHYSICIAN TRIED TO PERFORM A SECOND CUTTING PROCEDURE AND WHEN THE SPHINCTEROTOME WAS TWISTED THE TIP OF THE WIRE [CUTTING WIRE SECURING COMPONENT] GOT [CAME] OUT OF 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 11858217 ↗
• MalfunctionMar 2, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING WAS INITIALLY REPORTED TO THE FDA ¿DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP), WHEN THE SPHINCTERTOME WAS OPENED IT WAS NOTICED THAT A PIECE OF PLASTIC WAS LOCATED ON THE TIP. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. A PHOTO OF THE DEVICE WAS RECEIVED ON 12-FEB-2020 THAT SHOWED A SECTION OF THE CATHETER PROTRUDING FROM THE PATIENT END OF THE DEVICE. 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.¿ THE FOLLOWING PATIENT OUTCOME WAS RECEIVED 03-MAR-2020. 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 9774976 ↗
• MalfunctionMar 15, 2019Peeled/Delaminated; Positioning Problem; Peeled/Delaminated; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE WIRE GUIDE COATING STRIPPED OFF WHICH MADE IT DIFFICULT FOR EXCHANGES. THE DEVICE WAS REMOVED, NOTHING DETACHED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN COMPETITORS DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COOK DISTRICT MANAGER ON 28-FEB-2019: "INITIALLY, THE SPHINCTEROTOME WAS REMOVED AND WE EXCHANGED FOR A COOK FUSION QUATTRO EXTRACTION BALLOON. THE PHYSICIAN EXPERIENCED DIFFICULTY GETTING THE BALLOON TO EXIT THE ENDOSCOPE AS WE DID NOT KNOW THE HYDROPHILIC COATING WAS STRIPPED OR WAS IN THE PROCESS OF STRIPPING AT THAT POINT. THE PHYSICIAN WAS ABLE TO COMPLETE ONE BALLOON CHOLANGIOGRAM, BUT WAS NOT HAPPY WITH HOW DIFFICULT EVERYTHING SEEMED TO BE. AT THAT POINT, HE PULLED BOTH THE WIRE GUIDE [LOST WIRE GUIDE ACCESS] AND BALLOON OUT OF THE ENDOSCOPE TO SWITCH TO A DIFFERENT WIRE. ANOTHER MANUFACTURER'S WIRE GUIDE WAS RELOADED INTO THE SPHINCTEROTOME PORTION OF THE ORIGINAL DEVICE. THE PHYSICIAN RECANNULATED THE BILE DUCT AND EXCHANGED BACK TO THE SAME BALLOON TO COMPLETE THE PROCEDURE." A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8424122 ↗
• MalfunctionFeb 10, 2017Improper or Incorrect Procedure or Method; Failure to Align; Improper or Incorrect Procedure or Method; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION WITH PRELOADED ACROBAT WIRE GUIDE. WHEN THEY OPENED THE PACKAGE AND REMOVED THE STYLET, POOR ORIENTATION AT THE TIP OF THE SPHINCTEROTOME WAS SEEN. THEY TESTED IT [THE DEVICE] AND SAW IN THE PAPILLA THE BAD ORIENTATION [THE CUTTING WIRE ORIENTED INCORRECTLY TO THE PAPILLA].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6322494 ↗
• MalfunctionJul 27, 2016Peeled/Delaminated; Peeled/Delaminated

  THIS REPORT SUMMARIZES TWO (2) MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDES. DURING THE PROCEDURES, THE USER EXPERIENCED DAMAGE TO THE COATING OF THE PRE-LOADED WIRE GUIDE. THERE WAS ONE (1) MALE PATIENT INVOLVED, WITH PRE-EXISTING COMMON BILE DUCT STONES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5827860 ↗
• MalfunctionJul 8, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE. A TEN (10) FRENCH STENT WAS BEING INSERTED OVER THE WIRE GUIDE USING A COOK FUSION OASIS ONE ACTION STENT INTRODUCTION SYSTEM. THE PLASTIC COVERING OF THE WIRE GUIDE COMPLETELY CAME AWAY FROM METAL SHAFT OF WIRE AND COULD BE SEEN AT AMPULLA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5779547 ↗