Fusion G34601Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10827002346014), received between Apr 26, 2016 and May 27, 2021 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2021Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE AND STATED THAT ON PLACING A 7F PIGTAIL STENT, ON REMOVAL OF THE WIRE TO DEPLOY THE STENT, A BLACK STRIP WAS SEEN IN THE LUMEN OF THE STENT WHICH WAS REMOVED WITH FORCEPS. THIS WAS APPROXIMATELY 10 INCHES OF THE WIRE COATING PRIOR TO THE FLEXIBLE WIRE TIP. A SECTION OF THE DEVICE DID 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: Foreign Body In Patient

  MAUDE report 11893575 ↗
• MalfunctionFeb 26, 2020Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. UPON REMOVING THE SPHINCTEROTOME FROM THE PACKAGING, THE WIRE WAS NOTICED TO BE PRELOADED BACKWARD WITH THE STIFF PORTION INSERTED IN THE FUSION OMNI-TOME. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPHINCTEROTOME. THIS EVENT WAS NOT REPORTABLE AT THE TIME. ON 30-JAN-2020 THE DEVICE WAS RECEIVED AND IT WAS DETERMINED THAT THE CUTTING WIRE SECURING COMPONENT SEPARATED FROM THE CATHETER. 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 9753406 ↗
• MalfunctionJan 31, 2020Malposition of Device; Malposition of Device

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. THE WIRE GUIDE [CUTTING WIRE] HAD POOR ORIENTATION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 Known Impact Or Consequence To Patient

  MAUDE report 9656144 ↗
• MalfunctionFeb 8, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY SPHINCTEROTOMY, THE PHYSICIAN USED THREE (3) COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTERTOMES. THE DOCTOR TRIED TO USE THE SPHINCTERTOMES, BUT THE TIP OF THE INSTRUMENT WENT IN THE WRONG DIRECTION; IT WAS NOT POSSIBLE TO CANNULATE THE BILE DUCT (SUBJECT OF THIS REPORT). THE CUSTOMER TOOK A COOK FUSION OMNI ERCP CATHETER AND THEN A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME, AND IT WORKED. THE CUSTOMER ALSO REPORTED INCORRECT ORIENTATION PRIOR TO USE REGARDING THE SAME DEVICE FROM A DIFFERENT LOT (SEE MDR 1037905-2019-00053). 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 8322945 ↗
• MalfunctionFeb 8, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY SPHINCTEROTOMY, THE PHYSICIAN USED THREE (3) COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOMES. THE DOCTOR TRIED TO USE THE SPHINCTEROTOMES, BUT THE TIP OF THE INSTRUMENT WENT IN THE WRONG DIRECTION; IT WAS NOT POSSIBLE TO CANNULATE THE BILE DUCT (SEE RELATED MDR 1037905-2019-00054). THE CUSTOMER TOOK A COOK FUSION OMNI ERCP CATHETER AND THEN A COOK FUSION TRIPLE LUMEN SPHINCTEROTOME, AND IT WORKED . THE CUSTOMER ALSO REPORTED INCORRECT ORIENTATION PRIOR TO USE REGARDING THE SAME DEVICE FROM A DIFFERENT LOT (SUBJECT OF THIS REPORT). THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8322942 ↗
• MalfunctionFeb 8, 2019Peeled/Delaminated; Peeled/Delaminated

  THE FOLLOWING WAS INITIALLY REPORTED TO THE FDA ON 08-FEB-2019: "DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION ® PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE WIRE GUIDE WAS COMPLETELY PEELED AT THE TIP INSIDE A COOK FUSION QUATTRO EXTRACTION BALLOON (FS-QEB-A). THE DOCTOR MET FRICTION WHEN USING THE EXTRACTION BALLOON ON THE WIRE GUIDE. THE WIRE GUIDE DID NOT MOVE AS BLOCKED [LOCKED] ON THE LOOKING [LOCKING] DEVICE. AFTER A FEW PASSAGES, MORE FRICTION [OCCURRED], AND THE END OF THE WIRE WAS COMPLETELY DESTROYED AT 20 CM FROM THE TIP OF THE WIRE. THE USER FACILITY ALSO REPORTED THAT THE EVENT OCCURRED WITH ONE (1) DEVICE PRIOR TO USE." ADDITIONAL INFORMATION WAS RECEIVED ON 14-FEB-2019: [THERE WAS] NO COMPLAINT ON THE PRIOR TO USE DEVICE. 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 8320606 ↗
• MalfunctionAug 31, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOMES. THE COATING OF THE WIRE GUIDE WAS PEELING OFF [COATING DAMAGE] DURING USE. ACCORDING TO THE CUSTOMER, THE PRODUCT [WIRE GUIDE] DID NOT RIP OFF [WHILE] IN CONTACT WITH THE ELEVATOR OF THE DUODENOSCOPE. 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 7839237 ↗
• InjuryAug 10, 2018Break; Break

  DURING A SPHINCTEROTOMY, THE PHYSICIAN USED A COOK FUSION OMNI PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE DISTAL END OF THE CUTTING WIRE SNAPPED AND APPROXIMATELY 1 CM WAS LEFT IN THE PATIENT' DUODENUM. THE PHYSICIAN WAS UNABLE TO GRASP IT [THE BROKEN PIECE]. THE PATIENT HAS BEEN SCANNED AND THE PIECE COULD NOT BE LOCATED. THE PATIENT WAS GOING TO HAVE A COMPUTED TOMOGRAPHY (CT) SCAN. AFTER SEVERAL ATTEMPTS TO ACQUIRE ADDITIONAL INFORMATION, IT IS UNKNOWN AT THIS TIME IF THE PATIENT WILL [NATURALLY] PASS THE WIRE PIECE OR IF SHE WILL REQUIRE SURGERY TO REMOVE THE BROKEN PIECE. A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. AN ATTEMPT WAS MADE TO RETRIEVE THE PIECE, BUT THE PHYSICIAN WAS UNSUCCESSFUL. THE PATIENT REQUIRED A CT SCAN DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. SEVERAL ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION ON IF THE PATIENT REQUIRED SURGERY, HOWEVER IT IS CURRENTLY UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7772097 ↗
• MalfunctionFeb 26, 2018Migration or Expulsion of Device; Use of Device Problem; Migration or Expulsion of Device; Use of Device Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOMES. THE CUSTOMER HAD DIFFICULTY REMOVING THE SPHINCTEROTOME, WITHOUT TAKING THE WIRE [OUT] AS WELL [LOST WIRE GUIDE ACCESS]. AS PER COMPLAINT FORM: THE WIRE BECAME STUCK IN THE SPHINCTEROTOME DURING THE PROCEDURE. THE CUSTOMER HAS SINCE BEEN ADVISED TO ENSURE THAT THE DEVICE IS FLUSHED WITH WATER PRIOR TO USE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 02/26/2018: THE WIRE WAS STUCK IN THE SPHINCTEROTOME, SO [THE WIRE] WAS REMOVED DURING THE EXCHANGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7297184 ↗
• MalfunctionOct 6, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE PROTECTIVE COVERING COMPLETELY SHEARED OFF THE WIRE [WIRE GUIDE COATING DAMAGE].

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6921628 ↗
• MalfunctionMar 3, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRELOADED ACROBAT WIRE GUIDE. THE WIRE GUIDE STRIPPED DURING THE PROCEDURE. WHEN A DILATOR WAS BEING REMOVED, THE DISTAL END OF THE WIRE GUIDE STRIPPED [COATING DAMAGE].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6376233 ↗
• MalfunctionJan 13, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE. THE SPHINCTEROTOME WENT DOWN THE ENDOSCOPE AND THE USER WENT TO STRIP THE WIRE AND REALIZED THE ANGLE OF THE SPHINCTEROTOME WAS GOING TO THE RIGHT (ORIENTATION OFF). THE DEVICE WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED FROM A DIFFERENT LOT SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6249569 ↗
• MalfunctionSep 9, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2016, THE FOLLOWING INFORMATION WAS RECEIVED: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE. DURING THE PEEL AWAY [EXCHANGE] OF THE SPHINCTEROTOME WITH THE WIRE GUIDE, IT HAD CREATED A TEAR IN THE SHEATH, THEREFORE IT WAS IMPOSSIBLE TO PULL OUT THE WIRE GUIDE WITHOUT PULLING THE ENTIRE CATHETER. ON (B)(6) 2016 WE RECEIVED THE FOLLOWING: THE USER LOST WIRE GUIDE ACCESS TO THE PAPILLA UNINTENTIONALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5939713 ↗
• MalfunctionSep 2, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE. THE WIRE GUIDE STRIPPED [COATING DAMAGE] DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED REGARDLESS. NO FURTHER DETAILS WERE PROVIDED. ON 08/17/2016 WE RECEIVED INFORMATION FROM THE SALES REPRESENTATIVE THAT THE DAMAGE WAS APPROXIMATELY 25 CM FROM THE DISTAL TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5924918 ↗
• MalfunctionAug 22, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE. THE WIRE STRIPPED [COATING DAMAGE] DURING THE PROCEDURE. THE DAMAGE OCCURRED AT APPROXIMATELY 12 INCHES (APPROXIMATELY 30.48 CM) FROM THE [DISTAL] END AND IS APPROXIMATELY 2.5 INCHES (APPROXIMATELY 6.38 CM) IN LENGTH. THE PROCEDURE WAS ABLE TO BE COMPLETED. NO FURTHER DETAILS WERE PROVIDED, OTHER THAN THE USER FACILITY QUESTIONS IF THE WIRE IS BEING STRIPPED ON THE FUJINON ENDOSCOPE ELEVATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5894568 ↗
• MalfunctionAug 11, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE. AFTER THE PHYSICIAN PULLED AN EXTRACTION BALLOON BACK, THE WIRE APPEARED TO STRIP/PEEL AT APPROXIMATELY 25 CM FROM THE DISTAL TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5870089 ↗
• MalfunctionAug 11, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE. THE WIRE GUIDE STRIPPED FROM APPROXIMATELY 25 CM FROM DISTAL TIP. THE PHYSICIAN RAN A LITHOTRIPSY DEVICE DOWN THE WORKING CHANNEL ALONGSIDE THE WIRE GUIDE [LITHOTRIPSY DEVICE WAS NOT ADVANCED OVER WIRE GUIDE]. THE CASE WAS FINISHED AND NO HARM CAUSED TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5870075 ↗
• MalfunctionAug 5, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE. DURING AN EXCHANGE WITH THE WIRE LOCKED IN THE COOK FUSION WIRE LOCK, IT WAS POSSIBLE TO WITHDRAW THE SPHINCTEROTOME APPROXIMATELY 50-60 CENTIMETERS. THEN, THE USER WAS UNABLE TO EXCHANGE. THE USER TRIED TO FORCE THE EXCHANGE BY HOLDING THE ORANGE SPLITTING TOOL BETWEEN THE WIRE AND THE CATHETER, BUT WITH NO SUCCESS. THE WIRE GUIDE WAS STUCK AND CAME OUT TOGETHER WITH THE CATHETER WHEN THEY TRIED TO REMOVE IT [LOST WIRE GUIDE ACCESS]. IN THIS CASE, THE SPHINCTEROTOME WAS DAMAGED AS WELL AS THE PRE-LOADED ACROBAT WIRE GUIDE [COATING DAMAGE] (SEE MDR 1037905-2016-00283).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5849717 ↗
• MalfunctionAug 5, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE. DURING AN EXCHANGE WITH THE WIRE LOCKED IN THE COOK FUSION WIRE LOCK, IT WAS POSSIBLE TO WITHDRAW THE SPHINCTEROTOME APPROXIMATELY 50-60 CENTIMETERS. THEN, THE USER WAS UNABLE TO EXCHANGE. THE USER TRIED TO FORCE THE EXCHANGE BY HOLDING THE ORANGE SPLITTING TOOL BETWEEN THE WIRE AND THE CATHETER, BUT WITH NO SUCCESS. THE WIRE GUIDE WAS STUCK AND CAME OUT TOGETHER WITH THE CATHETER WHEN THEY TRIED TO REMOVE IT [LOST WIRE GUIDE ACCESS] (SEE MDR 1037905-2016-00282). IN THIS CASE, THE SPHINCTEROTOME WAS DAMAGED AS WELL AS THE PRE-LOADED ACROBAT WIRE GUIDE [COATING DAMAGE].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5849713 ↗
• MalfunctionJun 24, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED WITH ACROBAT WIRE GUIDE. THE "ORIENTATION WAS TERRIBLE" [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5747712 ↗
• MalfunctionJun 24, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED WITH ACROBAT WIRE GUIDE. THE "ORIENTATION WAS TERRIBLE" [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5747711 ↗
• MalfunctionApr 26, 2016Peeled/Delaminated; Peeled/Delaminated

  THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES, THE PHYSICIANS USED COOK FUSION PRE-LOADED WITH ACROBAT CALIBRATED TIP WIRE GUIDES. DURING THE PROCEDURES, THE USERS EXPERIENCED COATING DAMAGE TO THE PRE-LOADED WIRE GUIDE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES ON VARIOUS DATES. ALL THREE (3) EVENTS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. ONE (1) OF THE PATIENTS WAS REPORTED TO BE FEMALE, AND ALSO HAD STONES IN THE COMMON BILE DUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5609711 ↗