Fusion G56103Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002561038), received between Mar 28, 2017 and Feb 22, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2022Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO CANNULATE THE PANCREATIC DUCT QUICKLY; REMOVED THE SPHINCTEROTOME OFF OF THE WIRE GUIDE, LEAVING THE WIRE GUIDE IN THE PATIENT. THE PHYSICIAN THEN USED A GLOW-TIP ERCP CANNULA. THE WIRE GUIDE WOULD NOT COME OFF OF THE GLOW-TIP ERCP CANNULA. WHEN THE PHYSICIAN REMOVED THE WIRE GUIDE AND THE ERCP CANNULA, THE BLACK COATING WAS BUNCHED UP ON THE TIP. [COATING DAMAGE, SUBJECT OF REPORT]. COMPLETED THE PROCEDURE WITH ANOTHER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13577325 ↗
• MalfunctionSep 3, 2020Peeled/Delaminated; Peeled/Delaminated

  PRIOR TO AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PHYSICIAN SELECTED A FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE DEVICE CAME WITH A FRAYED WIRE. THEY WERE ABLE TO USE THE SPHINCTEROTOME PORTION OF THE DEVICE, BUT HAD TO REPLACE THE PRE-LOADED SPHINCTEROTOME WIRE GUIDE. THE WIRE GUIDE OF THE DEVICE WAS RECEIVED FOR EVALUATION ON 20-AUG-2020. A PORTION OF THE BLACK COATING AT THE TIP HAS COME OFF. IT IS STILL ATTACHED TO THE CORE WIRE BUT THE CORE WIRE IS UNRAVELED [SUBJECT OF THE REPORT]. THIS OCCURRED PRIOR TO PATIENT CONTACT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10488823 ↗
• MalfunctionNov 16, 2018Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. AT THE TIME OF MAKING THE SPHINCTEROTOMY, THE CUTTING WIRE BROKE (PULLED AWAY FROM THE CATHETER) [CUTTING WIRE SECURING COMPONENT SEPARATED FROM CATHETER]. IT WAS STILL CONNECTED AT THE OTHER END. AT THIS POINT, THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 8077448 ↗
• MalfunctionSep 10, 2018Migration or Expulsion of Device; Peeled/Delaminated; Detachment of Device or Device Component; Migration or Expulsion of Device; Peeled/Delaminated; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE COATING CAME OFF THE WIRE GUIDE. [THE USER] WAS UNABLE TO EXCHANGE OVER THE WIRE GUIDE. ANOTHER SPHINCTEROTOME AND WIRE GUIDE WAS USED TO CANNULATE [LOSS OF WIRE GUIDE ACCESS]. CLARIFICATION RECEIVED ON 24-AUG-2018: IT LOOKS LIKE PROBLEM [COATING DAMAGE] OCCURRED AT TIP OF WIRE GUIDE (5 CM). 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 7861180 ↗
• MalfunctionJun 15, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE. THE ORIENTATION OF THE SPHINCTEROTOME WAS NOT CORRECT AND IT KEPT POINTING IN A 9 O'CLOCK POSITION. THEREFORE, THE DOCTOR KEPT CANNULATING THE PANCREATIC DUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7605176 ↗
• MalfunctionDec 4, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE SPHINCTEROTOME WAS POINTING TO THE LEFT MORE THAN NORMAL [INCORRECT CUTTING WIRE ORIENTATION]. WHEN BOWING, IT POINTED EVEN MORE TO THE LEFT WHICH MADE CANNULATION IMPOSSIBLE. THE DOCTOR HAD TO MOVE TO A LONG-WIRE COOK DASH SPHINCTEROTOME TO COMPLETE CANNULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7078442 ↗
• MalfunctionDec 1, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. WHEN THE PHYSICIAN TRIED TO PULL THE CATHETER OUT OF THE ENDOSCOPE, THE WIRE WOULD NOT SPLIT THE CATHETER AND THE LOOP [CAME] OUT OF THE LOCK. THIS MEANT THE PHYSICIAN KEPT LOSING POSITION [LOST WIRE GUIDE ACCESS](SEE RELATED MDR 1037905-2017-00723 AND MDR 1037905-2017-00724). THIS SEEMED TO HAPPEN WHILE THE SPHINCTEROTOME WAS STILL INSIDE THE DUCT. THE NURSE HAD TO PUT PRESSURE ON THE WIRE AT THE WIRE LOCK SO THE WIRE WOULD STAY STIFF AND STABLE ENOUGH FOR THE CATHETER TO SPLIT. ONCE THE CATHETER WAS PULLED PAST THE BRIDGE INTO THE ENDOSCOPE CHANNEL, IT SEEMED TO START SPLITTING ASIDE. THE EXCHANGE AT THE WIRE LOCK WAS STILL VERY STIFF AND DIFFICULT. THE ADDITIONAL INFORMATION PROVIDED INDICATES THE SPHINCTEROTOME INCORRECTLY ORIENTATED PRIOR TO BOWING AND UPON BOWING THE DEVICE (SUBJECT OF THIS REPORT AND ALSO SEE RELATED MDR 1037905-2017-00726).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7074962 ↗
• MalfunctionDec 1, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. WHEN THE PHYSICIAN TRIED TO PULL THE CATHETER OUT OF THE ENDOSCOPE, THE WIRE WOULD NOT SPLIT THE CATHETER AND THE LOOP [CAME] OUT OF THE LOCK. THIS MEANT THE PHYSICIAN KEPT LOSING POSITION [LOST WIRE GUIDE ACCESS] (SEE RELATED MDR 1037905-2017-00723 AND MDR 1037905-2017-00724). THIS SEEMED TO HAPPEN WHILE THE SPHINCTEROTOME WAS STILL INSIDE THE DUCT. THE NURSE HAD TO PUT PRESSURE ON THE WIRE AT THE WIRE LOCK SO THE WIRE WOULD STAY STIFF AND STABLE ENOUGH FOR THE CATHETER TO SPLIT. ONCE THE CATHETER WAS PULLED PAST THE BRIDGE INTO THE ENDOSCOPE CHANNEL, IT SEEMED TO START SPLITTING ASIDE. THE EXCHANGE AT THE WIRE LOCK WAS STILL VERY STIFF AND DIFFICULT. THE ADDITIONAL INFORMATION PROVIDED INDICATES THE SPHINCTEROTOME INCORRECTLY ORIENTATED PRIOR TO BOWING AND UPON BOWING THE DEVICE (SUBJECT OF THIS REPORT AND ALSO SEE RELATED MDR 1037905-2017-00725).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7074954 ↗
• MalfunctionDec 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. WHEN THE PHYSICIAN TRIED TO PULL THE CATHETER OUT OF THE ENDOSCOPE, THE WIRE WOULD NOT SPLIT THE CATHETER AND THE LOOP [CAME] OUT OF THE LOCK. THIS MEANT THE PHYSICIAN KEPT LOSING POSITION [LOST WIRE GUIDE ACCESS] (SUBJECT OF THIS REPORT AND ALSO SEE RELATED MDR 1037905-2017-00724). THIS SEEMED TO HAPPEN WHILE THE SPHINCTEROTOME WAS STILL INSIDE THE DUCT. THE NURSE HAD TO PUT PRESSURE ON THE WIRE AT THE WIRE LOCK SO THE WIRE WOULD STAY STIFF AND STABLE ENOUGH FOR THE CATHETER TO SPLIT. ONCE THE CATHETER WAS PULLED PAST THE BRIDGE INTO THE ENDOSCOPE CHANNEL, IT SEEMED TO START SPLITTING ASIDE. THE EXCHANGE AT THE WIRE LOCK WAS STILL VERY STIFF AND DIFFICULT. THE ADDITIONAL INFORMATION PROVIDED INDICATES THE SPHINCTEROTOME INCORRECTLY ORIENTATED PRIOR TO BOWING AND UPON BOWING THE DEVICE (SEE RELATED MDR 1037905-2017-00725 AND MDR 1037905-2017-00726).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7074605 ↗
• MalfunctionDec 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. WHEN THE PHYSICIAN TRIED TO PULL THE CATHETER OUT OF THE ENDOSCOPE, THE WIRE WOULD NOT SPLIT THE CATHETER AND THE LOOP [CAME] OUT OF THE LOCK. THIS MEANT THE PHYSICIAN KEPT LOSING POSITION [LOST WIRE GUIDE ACCESS] (SUBJECT OF THIS REPORT AND ALSO SEE RELATED MDR 1037905-2017-00723). THIS SEEMED TO HAPPEN WHILE THE SPHINCTEROTOME WAS STILL INSIDE THE DUCT. THE NURSE HAD TO PUT PRESSURE ON THE WIRE AT THE WIRE LOCK SO THE WIRE WOULD STAY STIFF AND STABLE ENOUGH FOR THE CATHETER TO SPLIT. ONCE THE CATHETER WAS PULLED PAST THE BRIDGE INTO THE ENDOSCOPE CHANNEL, IT SEEMED TO START SPLITTING ASIDE. THE EXCHANGE AT THE WIRE LOCK WAS STILL VERY STIFF AND DIFFICULT. THE ADDITIONAL INFORMATION PROVIDED INDICATES THE SPHINCTEROTOME INCORRECTLY ORIENTATED PRIOR TO BOWING AND UPON BOWING THE DEVICE (SEE RELATED MDR 1037905-2017-00725 AND MDR 1037905-2017-00726).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7074600 ↗
• MalfunctionOct 13, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOMES. WHEN THE SPHINCTEROTOME EXITED THE ENDOSCOPE TO CANNULATE, THE SPHINCTEROTOME POINTED TO THE LEFT, AROUND 10 O¿CLOCK. WHEN THE DOCTOR ASKED FOR IT TO BOW UP, IT GOT EVEN WORSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6947499 ↗
• MalfunctionOct 10, 2017Material Frayed; Material Frayed

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. AFTER CANNULATION, THE DOCTOR WANTED TO EXCHANGE THE SPHINCTEROTOME LEAVING THE GUIDEWIRE IN PLACE. HE UNLOCKED THE WIRE AFTER HE PULLED THE SPHINCTEROTOME THROUGH THE ENDOSCOPE OVER THE WIRE, BUT WHEN THE NURSE TRIED TO DO THE EXCHANGE SHE COULD NOT PULL THE SPHINCTEROTOME OVER THE WIRE AS THE COATING HAD SHREDDED OFF [COATING DAMAGE]. WE THEN HAD TO START CANNULATING AGAIN WITH A NEW SPHINCTEROTOME AND WIRE [LOST WIRE GUIDE ACCESS]. THE DEVICE WAS EVALUATED ON 10/10/17 AND IT WAS OBSERVED THE COIL SPRING ASSEMBLY DETACHED FROM THE CORE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6938902 ↗
• MalfunctionMay 17, 2017Material Frayed; Material Frayed

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. UPON STRIPPING THE WIRE DOWN, THE WIRE GUIDE AND CATHETER BOTH BEGAN TO UNRAVEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6572012 ↗
• MalfunctionMar 28, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. WHEN USING THE DEVICE, THE ORIENTATION OF THE DEVICE CAME OUT AT 9 O'CLOCK RATHER THAN 12 O'CLOCK [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439195 ↗