Fusion G55814Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00827002558144), received between Apr 26, 2016 and Jan 27, 2023 — classified as 58 malfunctions.

The most frequently reported specific device problem is “Material Separation” (25 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2023Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. IT WAS REPORTED THAT THE CUTTING CABLE IN SPHINCTEROTOME BROKE ON THE PROXIMAL END. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED THAT APPROXIMATELY 4.5 CM IS MISSING FROM THE CUTTING WIRE. [SUBJECT OF REPORT] ACCORDING TO THE INITIAL REPORTER, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY, BUT A PORTION OF THE CUTTING WIRE MEASURING APPROXIMATELY 4.5 CM IS MISSING AND WAS NOT INCLUDED IN THE RETURN OF THE DEVICE. ACCORDING TO THE REPORTER THE MISSING PORTION WAS NOT FOUND. NO FURTHER INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, AND IT WAS STATED THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16255201 ↗
• MalfunctionSep 13, 2022Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. IT WAS INITIALLY REPORTED THAT THERE WAS A FAULTY WIRE DURING SPHINCTEROTOMY. THE CUTTING WIRE ON THE SPHINCTEROTOME BROKE AFTER 2 SUCCESSFUL CUTS. NO HARM TO PATIENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER REPLY WITH IMAGE RECEIVED ON (B)(6) 2022 THE CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF DEVICE. [SUBJECT OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15414425 ↗
• MalfunctionApr 4, 2022Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED TWO (2) COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOMES. IT WAS INITIALLY REPORTED THAT THE CUTTING WIRES BECAME "DAMAGED/BROKE." THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER CLARIFICATION RECEIVED ON 03/07/2022 THE CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF THE DEVICE. [SUBJECT OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13996955 ↗
• MalfunctionApr 2, 2021Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. PER THE USER, "WHEN THE WIRE IS CLAMPED, IT IS TORN [CUTTING WIRE BREAKS IN ONE LOCATION]. AFTER THE EXAMINATION [PROCEDURE], THE ENDOSCOPE HAD DAMAGE TO THE WORKING CHANNEL.' THIS EVENT WAS NOT CONSIDERED REPORTABLE AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 10-MAR-2021. THE ANCHOR HAD SEPARATED FROM THE TIP. 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 11607624 ↗
• MalfunctionMar 22, 2021Material Separation; Material Separation

  DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. AS THE PHYSICIAN WAS GOING TO EXTEND THE DEVICE, HE NOTICED THAT THE CUTTING WIRE HAD BROKE, IT DID NOT DETACH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. CLARIFICATION WAS RECEIVED ON 25-FEB-2021 AND IT WAS NOTED THAT THE CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF DEVICE [SUBJECT OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11541778 ↗
• MalfunctionJan 22, 2021Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. AS THE PHYSICIAN TRIED TO CANNULATE THE PAPILLA MAJOR AND PUT CURRENT ON THE CUTTING WIRE, THE CUTTING WIRE BROKE. ANOTHER SPHINCTEROTOME WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THIS DEVICE RETURNED 30-DEC-2020. IT WAS DETERMINED THE CUTTING WIRE SECURING COMPONENT SEPARATED FROM THE TIP [SUBJECT OF 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 11214274 ↗
• MalfunctionNov 19, 2020Separation Failure; Separation Failure

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE GUIDE WIRE WAS STUCK IN THE SPHINCTEROTOME. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. CLARIFICATION WAS RECEIVED ON 30-OCT-2020 THAT THE DEVICES WERE STUCK AFTER BILIARY ACCESS WAS ACHIEVED. THE ACCESS WAS VERY EASY, NO STRUGGLING OR NEED TO USE THE SCOPES BRIDGE. THE CUT HAD BEEN MADE SO THERE WAS NO NEED TO USE A SECOND TOME. THEY WENT STRAIGHT IN WITH A BALLOON. BUT, HAD TO DO IT WITHOUT THE BENEFIT OF A GUIDE WIRE [LOSS OF WIRE GUIDE ACCESS AND SUBJECT OF 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 10870002 ↗
• MalfunctionOct 28, 2020Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE CUTTING WIRE BROKE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE COMPLAINT FORM AND CLARIFICATION WAS RECEIVED ON (B)(6) 2020 NOTING THE CUTTING WIRE ON THE SPHINCTEROTOME DETACHED [CUTTING WIRE SECURING COMPONENT SEPARATED] AT THE PATIENT END DURING CUTTING. 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 10750580 ↗
• MalfunctionJul 31, 2020Malposition of Device; Malposition of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. IT WAS NOTED THAT THE TIP APPEARED TO BE TWISTED [INCORRECT CUTTING WIRE ORIENTATION] AND IT WOULD NOT BOW CORRECTLY. IT IS NOT CONFIRMED IF THIS WAS NOTED OUT OF THE PACKAGE OR AFTER THE PROCEDURE STARTED. ANOTHER OF THE SAME DEVICE WAS USED WITH NO FURTHER COMPLICATIONS. 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 10349923 ↗
• MalfunctionFeb 24, 2020Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE CUTTING WIRE ON THE SPHINCTEROTOME BROKE DURING THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING WAS RECEIVED ON (B)(6) 2020: THE CUTTING WIRE SECURING COMPONENT [ANCHOR] SEPARATED FROM THE CATHETER. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED A SECTION OF THE CUTTING WIRE SECURING COMPONENT IS MISSING AND WAS NOT INCLUDED IN THE RETURN OF THE DEVICE. THIS INFORMATION WAS COMMUNICATED TO THE USER FACILITY AND THE LOCATION OF THE MISSING SECTION IS UNKNOWN. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE LOCATION OF THE MISSING SECTION DETECTED DURING OUR LABORATORY EVALUATION IS UNKNOWN. 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; No Consequences Or Impact To Patient

  MAUDE report 9747093 ↗
• MalfunctionFeb 19, 2020Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE SPHINCTEROTOME WIRE SNAPPED [BROKE] DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT PRODUCT. THIS EVENT WAS NOT REPORTABLE AT THE TIME. ON 23-JAN-2020 A PHOTO AND CLARIFICATION WAS RECEIVED NOTING THE CUTTING WIRE SECURING COMPONENT [ANCHOR] 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 9729126 ↗
• MalfunctionNov 11, 2019Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. WHILE BOWING THE SPHINCTEROTOME, THE PHYSICIAN AND COOK DISTRICT MANAGER HEARD A SNAP AND THE CUTTING WIRE BROKE ON THE PATIENT END OF THE DEVICE. IT APPEARED AS THOUGH THE DISTAL METAL TIP PULLED OUT OF THE PLASTIC OF THE TOME COMPLETELY [CUTTING WIRE SECURING COMPONENT SEPARATED FROM CATHETER]. THE PROCEDURE WAS COMPLETED WITH ANOTHER COOK SPHINCTEROTOME. 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 9306018 ↗
• MalfunctionSep 30, 2019Material Separation; Material Separation

  DURING A PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE CUTTING WIRE BROKE DURING THE PROCEDURE AND BLOCKED THE SPHINCTEROTOME IN THE DUODENOSCOPE WHEN THE DOCTOR WANTED TO EXTRACT THE SPHINCTEROTOME FROM THE DUODENOSCOPE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 05-SEP-2019 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 9136868 ↗
• MalfunctionFeb 25, 2019Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE CUTTING WIRE SNAPPED AT THE DISTAL END FROM THE SPHINCTEROTOME [CUTTING WIRE BREAKS IN ONE LOCATION] AS THE SPHINCTEROTOMY WAS BEING PERFORMED. NO CURRENT RAN THROUGH THE CUTTING WIRE AND IT WAS SAFELY TAKEN OUT AND REPLACED WITH ANOTHER SPHINCTEROTOME. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. CLARIFICATION WAS RECEIVED ON 01/21/2019: THE CUTTING WIRE BROKE IN ONE (1) LOCATION WITH NO DETACHMENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 01/31/2019. THE CUTTING WIRE SECURING COMPONENT WAS SEPARATED FROM THE TIP OF 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 8367140 ↗
• MalfunctionDec 3, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. [THERE WAS AN] ORIENTATION PROBLEM. ADDITIONAL INFORMATION WAS RECEIVED ON 14-NOV-2018: [THERE WAS AN] ORIENTATION PROBLEM. THE DEVICE WAS REMOVED AND ANOTHER ONE WAS OPENED. 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 8124061 ↗
• MalfunctionNov 6, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THERE WAS AN [INCORRECT CUTTING WIRE] ORIENTATION PROBLEM. 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 8042972 ↗
• MalfunctionOct 5, 2018Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE TIP OF SPHINCTEROTOME WAS TOTALLY TWISTED, WITH WRONG ORIENTATION [INCORRECT CUTTING WIRE ORIENTATION]. THE FOLLOWING INFORMATION WAS ALSO PROVIDED PER THE COMPLAINT FORM: THE PRODUCT HAD REAL BAD ORIENTATION, NOT COVERING MAIN FEATURE OF THE DEVICE. THEY HAD TO USE A NEW ONE FROM OUR COMPETITORS. 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 7937940 ↗
• MalfunctionOct 5, 2018Migration or Expulsion of Device; Peeled/Delaminated; Migration or Expulsion of Device; Peeled/Delaminated

  DURING TWO (2) ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. WHEN THE PHYSICIAN REMOVED THE SPHINCTEROTOME FROM THE ENDOSCOPE, HE HAD GREAT DIFFICULTY OPENING THE CATHETER [DIFFICULT ZIP EXCHANGE] WHICH TWISTED. THE WIRE GUIDE WAS REMOVED OUT OF THE BILIARY DUCT [LOST WIRE GUIDE ACCESS] AND THE PHYSICIAN HAD TO USE ANOTHER SPHINCTEROTOME. 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 7937905 ↗
• MalfunctionSep 7, 2018Migration or Expulsion of Device; Peeled/Delaminated; Migration or Expulsion of Device; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. [IT WAS] DIFFICULT TO EXCHANGE THE SPHINCTEROTOME AS THE PROTECTIVE COATING CAME OFF WIRE GUIDE [COATING DAMAGE]. THE SPHINCTEROTOME WAS KINKED DURING EXCHANGE AS THERE WAS LOTS OF RESISTANCE. ANOTHER SPHINCTEROTOME AND WIRE GUIDE WERE USED TO CANNULATE [INDICATING LOSS OF WIRE GUIDE ACCESS]. CLARIFICATION RECEIVED ON 24-AUG-2018. THE PRODUCT WAS IN A SEALED BAG. IT LOOKED APPROXIMATELY 20-30 CM FROM THE TIP OF THE WIRE GUIDE. I CANNOT BE 100 PERCENT SURE AS I HAVE NOT TAKEN THE CONTAMINATED PRODUCT OUT OF BAG. ADDITIONAL CLARIFICATION WAS RECEIVED ON 12-SEP-2018. THE INFORMATION PROVIDED STATES THAT THE USER WOULD HAVE STRIPPED DOWN THE SPHINCTEROTOME USING THE ORANGE STRIPPING TOOL PROVIDED. THE HOLE WAS CREATED IN THE CATHETER TO PERFORM THE EXCHANGE. THEY BACK LOADED THE SPHINCTEROTOME AND PUSHED THE WIRE THROUGH THE BREAKOUT CHANNEL NEAR THE METAL BAND. THE HOLE WAS CREATED BECAUSE THEY NEEDED TO GO DOWN WITH THE SPHINCTEROTOME AGAIN TO EXTEND THE SPHINCTEROTOMY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7856843 ↗
• MalfunctionJul 5, 2018Migration 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. THE CATHETER TWISTED ON ITSELF, THE WIRE GUIDE MOVED BACK UP ON THE CATHETER, FORMED A LOOP, DESPITE THE WIRE LOCK AND CAME OUT OF THE BILIARY TRACT [LOSS OF WIRE GUIDE ACCESS] (SUBJECT OF THIS REPORT). THE DEVICES WERE NOT BROKEN, THEY WERE STILL USED. THERE WAS NO PATIENT INJURY. THERE WAS A WASTE OF TIME DURING THE PROCEDURE. (THE USER ALSO REPORTED THAT) INCIDENTS HAPPENED EVERY SECOND TIME WITH THESE DEVICES (SEE RELATED MDR 1037905-2018-00303). 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 7665212 ↗
• MalfunctionJul 3, 2018Failure to Align; Failure to Align

  DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: "USED A SIDE VIEWING OLYMPUS GIF-180V ENDOSCOPE DURING ERCP YESTERDAY. THE COOK DISTRICT SALES MANAGER WAS THERE. [DURING] CANNULATION OF THE BILE DUCT, [GETTING] ACCESS WAS DIFFICULT AND REQUIRED USE OF A NEEDLE KNIFE. GAINED ACCESS WITH THE DEVICE, BUT YOU CAN SEE FROM THE IMAGES THAT THE ORIENTATION IS SLIGHTLY TOWARDS 10 O'CLOCK. IT WAS WORSE WITH MORE CATHETER OUT OF THE ENDOSCOPE AND CORRECTED MORE WHEN THE TECHNICIAN ¿BOWED¿ THE SPHINCTEROTOME."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7660034 ↗
• MalfunctionJul 2, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING A SPHINCTEROTOMY, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE PEELING OF THE CATHETER WAS VERY BAD [DIFFICULTY SPLITTING]. THEY NEEDED TO USE A NEW PRODUCT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. COMPLAINT FORM RECEIVED ON (B)(6) 2018: AFTER CUTTING THE PAPILLA, THEY TRIED TO DO THE EXCHANGE. IT WAS NOT POSSIBLE TO DO THE PEELING CORRECTLY. THEY LOST THE WIRE [LOST WIRE GUIDE ACCESS] AND THEY NEEDED TO RECANNULATE WITH ANOTHER SPHINCTEROTOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7656315 ↗
• MalfunctionMay 25, 2018Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. [WHILE THE USER WAS] TRYING TO TENSION THE CUTTING WIRE TO CUT THE PAPILLA, THE CUTTING WIRE BROKE BEFORE USING CURRENT. CLARIFICATION WAS RECEIVED ON 04/30/2018 FROM THE COOK SALES REPRESENTATIVE THAT STATED THE CUTTING WIRE [SECURING COMPONENT] ANCHOR SEPARATED FROM THE CATHETER. ON 05/07/2018, WE RECEIVED THE DEVICE FOR EVALUATION AND A 3 MM PORTION WAS MISSING.

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

  MAUDE report 7545130 ↗
• MalfunctionApr 13, 2018Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOMES. THE SPHINCTEROTOME WIRE GUIDE BREAK-THROUGH CHANNEL WAS VERY HARD TO BREAK, AND CREATED A LONG STRING OF PLASTIC COMING FROM THE SPHINCTEROTOME. THIS CAUSED THE PULLING OF THE WIRE GUIDE OUT OF THE PANCREATIC DUCT AND LOSING CANNULATION [LOST WIRE GUIDE ACCESS] [SEE RELATED MDR 1037905-2018-00106]. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 02/26/2018: THE WIRE-GUIDE BREAK-THROUGH CHANNEL WAS TOO DIFFICULT TO PEEL-OFF, AND A LONG STRING OF PLASTIC CAME FROM THE SPHINCTEROTOME. ALL THIS ENDED BY LOSING THE WIRE GUIDE FROM THE PANCREATIC DUCT [LOST WIRE GUIDE ACCESS] AND EXTENDING THE INTERVENTION (ANESTHESIA, X-RAYS) [SEE RELATED MDR 1037905-2018-00106]. THE DEVICE WAS EVALUATED ON 03/20/2018 AND IT WAS OBSERVED THAT THE CUTTING WIRE SECURING COMPONENT HAD ALSO SEPARATED [SUBJECT OF THIS REPORT].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7430580 ↗
• MalfunctionMar 23, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THERE WAS AN ORIENTATION ISSUE. THE BILE DUCT WAS NOT CANNULATED, DUE TO THE WRONG AXIS DIRECTION [INCORRECT CUTTING WIRE ORIENTATION] AFTER SEVERAL TRIALS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER USING ANOTHER MANUFACTURER'S SPHINCTEROTOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7365023 ↗