Fusion G31911Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00827002319110), received between Apr 26, 2016 and Jan 21, 2022 — classified as 1 injury, 40 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (18 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 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 THE SPHINCTEROTOME "SNAPPED WHEN BOWING." THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE ON (B)(6) 2021 DETERMINED THAT THE CUTTING WIRE SECURING COMPONENT HAD SEPARATED FROM THE TIP. ACCORDING TO THE INITIAL REPORTER, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY, BUT A SECTION OF THE CUTTING WIRE SECURING COMPONENT HAD BROKEN AND DETACHED FROM THE DEVICE, AND WAS NOT INCLUDED IN THE RETURN OF THE DEVICE. 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314174 ↗
• MalfunctionDec 15, 2021Material 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 THE CUTTING WIRE BROKE WHEN THEY [MEDICAL STAFF] WAS DOING A SPHINCTEROTOMY. THE SCOPE WAS IN THE DUODENUM. THEY [MEDICAL STAFF] FINISHED THE CASE BY USING ANOTHER FS-OMNI-35. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER COMMUNICATION RECEIVED ON 11/16/2021: THE CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF DEVICE AND DETACHED IN THE PATIENT. [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 AND NO INFORMATION WAS PROVIDED OF HOW THE DETACHED ANCHOR WAS RETRIEVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011764 ↗
• MalfunctionDec 9, 2020Malposition of Device; Malposition of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE TIP LOOKED "ODD" PRIOR TO USE AND IT WAS CLEARLY DISORIENTATED WHEN IT CAME INTO ENDOSCOPIC VIEW. THE TIP INITIALLY POINTED AT APPROXIMATELY 1 O'CLOCK, BUT WHEN THE CATHETER WAS ADVANCED IT TWISTED TO 9 O'CLOCK. A NEW DEVICE WAS OPENED AND USED TO CONTINUE. 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 10978990 ↗
• MalfunctionJul 19, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME, [THE USER EXPERIENCED AN] ORIENTATION PROBLEM. THEY OPENED ANOTHER SAME DEVICE AND COMPLETED 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 8809038 ↗
• MalfunctionJun 21, 2019Material Separation; Material Separation

  PRIOR TO AN ENDOSCOPIC PROCEDURE, THE USER CHOSE A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE SPHINCTEROTOME WAS BROKEN PRIOR TO THE PROCEDURE AND A NEW ONE WAS USED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED ON 28-MAY-2019 AND THE EVALUATION FOUND THAT THE CUTTING WIRE SECURING COMPONENT WAS SEPARATED FROM THE CATHETER. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8724156 ↗
• MalfunctionMay 9, 2019Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. AS PER THE CUSTOMER REPORT FROM MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA): "SPHINCTEROTOME CUTTING WIRE REPORTED AS SNAPPED DURING USE." PHOTOS PROVIDED FROM THE CUSTOMER SHOW THAT THE CUTTING WIRE SECURING COMPONENT SEPARATED FROM THE CATHETER. OUR ATTEMPTS TO COLLECT SPECIFIC PATIENT OUTCOME INFORMATION WERE UNSUCCESSFUL. BECAUSE THE COMPLAINANT STATED THAT THERE WAS "NO INJURY" TO THE PATIENT, WE CAN CONCLUDE THAT THIS INFORMATION DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8596774 ↗
• MalfunctionFeb 22, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE SPHINCTEROTOME BEHAVED IN AN UNUSUAL AND TWISTING MANNER. THIS MADE CORRECT ORIENTATION IMPOSSIBLE, IN AND OUT OF THE BODY. HE TRIED TO MANIPULATE THE UNNATURAL CURVE IN HIS HAND WITHOUT SUCCESS. THE SPHINCTEROTOME WAS REPLACED BY A COOK FUSION OMNI-TOME SPHINCTEROTOME, WHICH WORKED PERFECTLY AND WAS A SUCCESSFUL ERCP. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 01-FEB-2019 FROM THE DISTRIBUTION PARTNER: THE SPHINCTEROTOME WAS OUT OF THE ENDOSCOPE APPROXIMATELY FOUR (4) CM. IT APPEARED TO HAVE A SLIGHTLY STRANGE ORIENTATION PRIOR TO ENTRY INTO THE ENDOSCOPE. ON BOWING, IT [INCORRECT CUTTING WIRE ORIENTATION] WAS MUCH MORE SEVERE. 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 8361532 ↗
• MalfunctionJan 18, 2019Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. ACCORDING TO THE NURSE UNIT MANAGER (NUM), THE SPHINCTERTOME WAS PREPPED FOR USE AND HANDED TO THE DOCTOR TO INTRODUCE INTO THE ENDOSCOPE BIOPSY CHANNEL. IT WAS AT THIS POINT THAT THE DOCTOR NOTED THAT THE SPHINCTEROTOME TIP APPEARED TO BE MALFORMED. THIS CAN BE SEEN BY JUST THE TIP OF THE SPHINCTERTOME APPEARS TO HAVE BODY FLUID CONTAMINATION WHERE IT HAS COME IN CONTACT WITH THE BIOPSY CHANNEL BUTTON. THIS SPHINCTERTOME WAS KEPT FOR COLLECTION AND A NEW SPHINCTEROTOME WAS PREPARED AND USED SUCCESSFULLY TO COMPLETE THE CASE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED ON 26-DEC-2018, AND IT WAS DETERMINED THAT THE DISTAL END OF THE SPHINCTEROTOME WAS TWISTED AND POINTING IN THE WRONG DIRECTION. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8262532 ↗
• InjuryNov 19, 2018Material Fragmentation; Material Fragmentation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME (FS-OMNI-35). AT THE TIME OF SPHINCTEROTOMY, THE FS-OMNI-35 BROKE. THE CUTTING WIRE DETACHED FROM THE TIP OF THE CATHETER AND REMAINED STUCK IN THE BILE DUCT OF THE PATIENT. THE PHYSICIAN HAD TO REMOVE THE STUCK METAL TIP [CUTTING WIRE] BY USING AN EXTRACTION BALLOON AND OPENED A NEW FS-OMNI TO FINISH THE PROCEDURE. THE CUTTING SETTING WAS THE SAME AS THE PRIOR FS-OMNI. THE TIP OF CATHETER WAS NOT BENT MANUALLY. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY. THE CUTTING WIRE WAS REMOVED WITH AN EXTRACTION BALLOON 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 8084225 ↗
• MalfunctionAug 31, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE CUSTOMER HAD PROBLEMS WITH THE DIRECTION OF THE SPHINCTEROTOME [INCORRECT CUTTING WIRE ORIENTATION]. 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 7838558 ↗
• MalfunctionMay 25, 2018Material Separation; Material Separation

  DURING A SPHINCTEROTOMY, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE CUTTING WIRE BROKE. [THE DEVICE WAS] NOT IN A TORQUED POSITION, OR IN ANY UNUSUAL LONGER POSITIONS, AND THE USER DID NOT ROTATE THE DEVICE. THE DELAYED [DISTAL] CUTTING WIRE PULLED AWAY FROM THE CATHETER [CUTTING WIRE SECURING COMPONENT SEPARATION]. THE USER IMMEDIATELY REMOVED THE DEVICE FROM THE PATIENT. [THE USER] OPENED ANOTHER FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME TO COMPLETE THE PROCEDURE. [THERE WAS] NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7544097 ↗
• MalfunctionApr 20, 2018Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE CUTTING WIRE BROKE. ANOTHER SPHINCTEROTOME WAS USED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 03/26/2018. THE CUTTING WIRE SECURING COMPONENT HAS SEPARATED AT THE DISTAL END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7446780 ↗
• MalfunctionDec 21, 2017Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. AFTER THE SPHINCTEROTOME WAS INSERTED INTO THE ENDOSCOPE, INSIDE THE PATIENT, THE PHYSICIAN TRIED TO BOW THE SPHINCTEROTOME AND THE SPHINCTEROTOME WOULD NOT BOW. THE PHYSICIAN GAVE THE HANDLE A LITTLE MORE PRESSURE AND THE CUTTING WIRE SEPARATED FROM THE SPHINCTEROTOME [CUTTING WIRE SECURING COMPONENT SEPARATED FROM CATHETER] (SEE RELATED EMDR 1037905-2017-00784). THIS COMPLAINT DEVICE WAS REMOVED AND A NEW FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME WAS OPENED AND PLACED DOWN THE ENDOSCOPE AND INTO THE PATIENT. THE VERY SAME EVENT OCCURRED AS THE CUTTING WIRE SEPARATED FROM THIS SPHINCTEROTOME AS WELL [SUBJECT OF THIS REPORT]. A THIRD FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME WAS OPENED AND USED TO COMPLETE THE PROCEDURE." OUR EVALUATION OF THE RETURNED DEVICE DETERMINED A SECTION OF THE CUTTING WIRE SECURING COMPONENT HAS BROKEN AND DETACHED FROM THE DEVICE 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.

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

  MAUDE report 7138702 ↗
• MalfunctionDec 21, 2017Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. AFTER THE SPHINCTEROTOME WAS INSERTED INTO THE ENDOSCOPE, INSIDE THE PATIENT, THE PHYSICIAN TRIED TO BOW THE SPHINCTEROTOME AND THE SPHINCTEROTOME WOULD NOT BOW. THE PHYSICIAN GAVE THE HANDLE A LITTLE MORE PRESSURE AND THE CUTTING WIRE SEPARATED FROM THE SPHINCTEROTOME [CUTTING WIRE SECURING COMPONENT SEPARATED FROM CATHETER] (SUBJECT OF THIS REPORT). THIS COMPLAINT DEVICE WAS REMOVED AND A NEW FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME WAS OPENED AND PLACED DOWN THE ENDOSCOPE AND INTO THE PATIENT. THE VERY SAME EVENT OCCURRED AS THE CUTTING WIRE SEPARATED FROM THIS SPHINCTEROTOME AS WELL (SEE RELATED EMDR 107905-2017-00785). A THIRD FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138698 ↗
• MalfunctionDec 7, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE DISTAL TIP OF THE SPHINCTEROTOME APPEARED TORN WHEN BENDING IT TO GET INTO THE PAPILLA. THE SPHINCTEROTOME IS NOT STRAIGHT [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7095510 ↗
• MalfunctionNov 30, 2017Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE CUTTING WIRE DETACHED AT THE DISTAL END OF SPHINCTEROTOME [CUTTING WIRE BREAKS IN ONE LOCATION] DURING DIATHERMY. THE FOLLOWING WAS RECEIVED ON (B)(6) 2017: THE CUTTING WIRE BROKE OFF FROM THE DISTAL END OF THE SPHINCTEROTOME [CUTTING WIRE BREAKS IN ONE LOCATION] DURING CUTTING OF THE AMPULLA. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. CLARIFICATION WAS RECEIVED ON (B)(6) 2017: THE CUTTING WIRE SECURING COMPONENT WAS DISCONNECTED AT THE DISTAL END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7071493 ↗
• MalfunctionNov 17, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. [THE USER EXPERIENCED] POOR ORIENTATION. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 11/20/17: THE SPHINCTEROTOME ORIENTED BADLY MAKING CANNULATION OF THE AMPULLA VERY DIFFICULT, SO ANOTHER SPHINCTEROTOME WAS USED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7040483 ↗
• MalfunctionJun 12, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK FUSION OMNI-TOME SPHINCTEROTOMES. WHEN THE PHYSICIAN ADVANCED THE SPHINCTEROTOME OUT OF THE ENDOSCOPE IT POINTED TO THE LEFT WHICH MADE IT VERY DIFFICULT TO CANNULATE AS THE CORRECT ANGLE COULDN'T BE ACHIEVED [INCORRECT CUTTING WIRE ORIENTATION]. THERE WAS ALSO A DIVERTICULUM WHICH MAY HAVE ADDED TO THE MIS-ORIENTATION DUE TO AWKWARD POSITION OF THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6633087 ↗
• MalfunctionMay 17, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE ORIENTATION OF THE SPHINCTEROTOME WAS REPORTED TO BE FAULTY AND POINTING TOWARDS 10 O'CLOCK [INCORRECT CUTTING WIRE ORIENTATION]. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 5/3/17: THE ORIENTATION OF THE DEVICE WAS UNSATISFACTORY. IT WAS POINTING TOWARDS 10 O'CLOCK. THE SPHINCTEROTOME WAS USED TO CANNULATE A FEW TIMES AND AFTERWARDS IT RESEMBLED A CORK SCREW LIKE APPEARANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6572010 ↗
• MalfunctionMay 16, 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. THE CATHETER JAMMED IN THE ACCESSORY CHANNEL WHILE ATTEMPTING TO DO AN EXCHANGE AND FAILED TO STRIP. THE WIRE GUIDE CAME OUT WITH THE CATHETER AND DUCTAL ACCESS LOST [LOST WIRE GUIDE ACCESS].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6568985 ↗
• MalfunctionMay 12, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE ORIENTATION OF THE DISTAL TIP OF THE SPHINCTEROTOME WAS NOTED TO BE "UPSIDE DOWN" ONCE EXITING THE SCOPE AND THE GENERAL ORIENTATION OF THE DEVICE WAS UNSATISFACTORY [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6562801 ↗
• MalfunctionApr 7, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMN-TOME PRELOADED SPHINCTEROTOME. THE SPHINCTERTOME WAS VERY STIFF PASSING THROUGH THE SCOPE AND WHEN IT CAME THROUGH THE END OF THE SCOPE AT THE BILE DUCT, IT WAS TWISTED AND BENT. IT WAS PULLED OUT OF THE SCOPE. THE FOLLOWING CLARIFICATION WAS RECEIVED ON 2/23/17: THE CATHETER WAS BENT/TWISTED BUT CUTTING WIRE REMAINS CORRECTLY ORIENTED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. DURING EVALUATION OF THE RETURNED DEVICE ON 3/15/17, IT WAS OBSERVED THAT THE TIP OF THE CATHETER IS DISTORTED AND IS PROTRUDING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6473125 ↗
• MalfunctionMar 10, 2017Failure to Align; Failure to Align

  DURING THREE SEPARATE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURES (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE LOADED SPHINCTEROTOMES. DURING ERCP WHILE THE NURSES WERE STRIPPING THE WIRE THROUGH THE WORKING CHANNEL, IT WAS NOTED THAT THE STRIPPING WAS DIFFICULT. THE NURSES NOTED THAT ON THIS IMPROVED DESIGN THE STRIPPING WAS NOT FLUID AND DENTED PLASTIC WHICH HAD SOME IMPACT ON THE ORIENTATION (9 O'CLOCK) [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6395164 ↗
• MalfunctionFeb 17, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. THE DEVICE WAS ORIENTING TO THE RIGHT [INCORRECT CUTTING WIRE ORIENTATION], MAKING CANNULATION OF THE AMPULLA VERY DIFFICULT SO ANOTHER SPHINCTEROTOME WAS USED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6338954 ↗
• MalfunctionNov 22, 2016Migration 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. DURING A CATHETERIZATION OF THE PAPILLA, THE USER FOUND THAT THE SPHINCTEROTOME TORE DURING THE PEELING [EXCHANGE] LEADING TO A LOSS OF THE WAY [LOST WIRE GUIDE ACCESS]. ANOTHER SPHINCTEROTOME HAD TO BE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6122329 ↗