Fusion G31903Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 00827002319035), received between Apr 26, 2016 and Jul 1, 2026 — classified as 3 injuries, 136 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (75 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 139 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Detachment of Device or Device Component

  DURING COLON POLYP REMOVAL, THE PHYSICIAN USED A COOK ACUJECT VARIABLE INJECTION NEEDLE. IT WAS REPORTED THAT THE PHYSICIAN ADVANCED THE NEEDLE INTO ENDOSCOPE WORKING CHANNEL TO LESION AREA, THE PHYSICIAN PLANNED TO INJECT BUT NO RESPONSE FROM NEEDLE TIP. THE HANDLE HAD DETACHED FROM THE NEEDLE. [UNABLE TO INJECT] 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 25678192 ↗
• MalfunctionMay 22, 2026Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS REPORTED THAT THE DEVICE BROKE DURING AN ERCP. THE CUTTING WIRE DETACHED FROM THE TIP. THE TOME WAS THROWN AWAY. NO ADVERSE COMPLICATIONS FOR THE PATIENT. A NEW TOME WAS OPENED TO FINISH 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 25255497 ↗
• MalfunctionApr 27, 2026Accessory Incompatible; Sharp Edges

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE DUODENAL PAPILLA, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS REPORTED THAT DURING THE USE OF THE DEVICE, THE CUTTING WIRE BROKE, WHICH OCCURRED AFTER SUCCESSFUL INTUBATION BUT BEFORE THE STENT WAS PLACED. THE WIRE GUIDE CAME OUT FROM ANOTHER PORT INSTEAD OF THE WIRE GUIDE PORT. 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 25000058 ↗
• MalfunctionApr 24, 2026Accessory Incompatible; Sharp Edges

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS INITIALLY REPORTED THAT THE CUTTING WIRE TIP WAS DAMAGED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER OUR EVALUATION OF THE RETURNED DEVICE ON (B)(6) 2026, THE TIP OF THE CATHETER/WIRE GUIDE LUMEN IS DAMAGED AND THERE IS A BURR STICKING OUT. [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 24980769 ↗
• MalfunctionApr 20, 2026Separation Failure

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS REPORTED THAT IT WAS REALLY CHALLENGING TO SPLIT THE CATHETER. THEY [PHYSICIAN AND CREW] WERE EVENTUALLY ABLE TO SPLIT IT WITH EXTREME EFFORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. 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 24924221 ↗
• MalfunctionMar 18, 2026Sharp Edges

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS INITIALLY REPORTED THAT THE PHYSICIAN DETECTED THAT THE CUTTING WIRE ORIENTATION WAS NOT AS INTENDED EVEN AFTER SHAPING. THE PHYSICIAN CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED ON 13FEB2026 AND EVALUATED ON 20FEB2026. IT HAS BEEN IDENTIFIED THAT THERE IS NOTABLE DAMAGE AT THE CATHETER DISTAL TIP WITH BURRS/PROTRUSIONS. 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 24628197 ↗
• MalfunctionMar 9, 2026Separation Failure

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS REPORTED THAT DURING THE HOME [ZIP] EXCHANGE, THE CATHETER WAS NOT SPLITTING LIKE IT SHOULD. THE PROCEDURE WAS FINISHED BY TEARING THROUGH 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24543866 ↗
• MalfunctionFeb 24, 2026Sharp Edges

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS INITIALLY REPORTED THAT THE PHYSICIAN ADVANCED THE DEVICE INTO THE ENDOSCOPE AND FOUND THE CUTTING WIRE ORIENTATION DEVIATED AND COULD NOT COMPLETE CANNULATION. THIS INFORMATION IS NOT CONSIDERED A REPORTABLE EVENT. PER OUR EVALUATION ON 29 JAN 2026 OF THE RETURNED DEVICE, IT WAS NOTED THAT THERE APPEARS TO BE A BURR AT THE DISTAL 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24428308 ↗
• MalfunctionFeb 9, 2026Malposition of Device

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) COOK FUSION® OMNI-TOMES. IT WAS INITIALLY REPORTED THAT THERE WAS A FAULTY WIRE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER OUR EVALUATION OF THE DEVICE RETURNED ON 13 JAN 2026 THERE WAS DIFFICULTY TO PERFORM ZIP EXCHANGE. [SUBJECT OF REPORT]. ADDITIONAL INFORMATION WAS RECEIVED ON 23 JAN 2026 STATING THAT THE ANGULATION OF THE TOME WAS WRONG WHEN COMING OUT OF THE WORKING CHANNEL. WHEN THE HANDLE WAS USED TO INTRODUCE TENSION, THE ANGULATION WORSENED AND WAS NOT ABLE TO BE USED. 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 24292884 ↗
• MalfunctionDec 31, 2025Sharp Edges; Sharp Edges

  DURING AN ESOPHAGOGASTRODUODENOSCOPY, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS REPORTED THAT WHEN THE USER USED THE FS-OMNI TO OPEN THE SPHINCTER OF THE DUODENAL PAPILLA, A CRACK APPEARED IN THE PLASTIC TUBE AT THE FRONT END OF THE CUTTING WIRE, WHICH STUCK THE WIRE GUIDE AND PREVENTED THE PROCEDURE FROM BEING COMPLETED. THE PROCEDURE WAS COMPLETED AFTER REPLACING WITH ANOTHER FS-ONMI. 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 23933318 ↗
• MalfunctionDec 5, 2025Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS INITIALLY REPORTED THAT THE CUTTING WIRE BROKE. THIS WAS INTERPRETED AS CUTTING WIRE BREAKS (W/O DETACHMENT). THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. TWO (2) DEVICES WERE RETURNED AND WERE EVALUATED ON 10 NOV 2025. UPON EVALUATION IT WAS FOUND THAT, WHILE DEVICE #1 ALIGNED WITH CUTTING WIRE BREAKAGE IN ONE LOCATION, DEVICE #2 WAS FOUND TO HAVE HAD A PORTION OF THE CUTTING WIRE, INCLUDING THE ANCHOR, DETACH AND WAS NOT PROVIDED IN THE RETURN [SUBJECT OF THIS REPORT]. ACCORDING TO THE INITIAL REPORTER, 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 THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727783 ↗
• MalfunctionSep 19, 2025Separation Failure; Separation Failure

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS REPORTED THAT ONCE A SPHINCTEROTOMY WAS COMPLETED, THEY WENT TO REMOVE THE DEVICE. THE DEVICE WAS NOT SEPARATING FROM THE GUIDE WIRE LIKE IT SHOULD. AFTER A BIT OF TUGGING, THEY WERE ABLE TO REMOVE THE TOME FROM THE WIRE. THIS DID NOT CAUSE ANY PROBLEMS FOR THE PATIENT. THE PROCEDURE HAD ALREADY BEEN COMPLETED WITH THE DEVICE IN QUESTIONS WHEN THIS PROBLEM OCCURRED. 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 23096848 ↗
• MalfunctionNov 7, 2019Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. THE CUTTING WIRE BROKE DURING THE PROCEDURE. THEY HAD TO OPEN A NEW ONE TO FINISH PROCEDURE. THERE WAS NO HARM TO THE PATIENT. THE PICTURE PROVIDED FROM THE REPORTER INDICATES THAT THE CUTTING WIRE SECURING COMPONENT SEPARATED FROM THE CATHETER [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 9291877 ↗
• MalfunctionOct 24, 2019Material Fragmentation; Material Fragmentation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME. THE CUTTING WIRE BROKE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 30 SEP 2019 AND IT WAS DETERMINED THE CUTTING WIRE SECURING COMPONENT SEPARATED FROM THE CATHETER AND A PORTION DETACHED. THE DETACHED PORTION 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. IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE LOCATION OF THE MISSING PORTION 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: No Consequences Or Impact To Patient

  MAUDE report 9234534 ↗
• MalfunctionOct 11, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST), THE PHYSICIAN USED THE COOK FUSION OMNI-TOME SPHINCTEROTOME. THE DEVICE WAS INSERTED IN THE BODY THROUGH OLYMPUS'S JF-260V CHANNEL. WHEN THE TIP OF THE SPHINCTEROTOME CAME OUT OF THE ENDOSCOPE ABOUT 3 TO 4 CM (PRIOR TO BOWING), THE USER NOTICED THE DIRECTION OF THE CUTTING WIRE WAS NOT IN DESIRED DIRECTION [INCORRECT CUTTING WIRE ORIENTATION].THE DEVICE WAS REMOVED FROM THE ENDOSCOPE ONCE, THEN THE PHYSICIAN FORMED THE CUTTING WIRE DIRECTION BY HIS HANDS AND IT WAS INSERTED INTO THE PATIENT BODY FOR THE SECOND ATTEMPT OF EST AND THE EST 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 Consequences Or Impact To Patient

  MAUDE report 9179851 ↗
• MalfunctionAug 21, 2019Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. THEY WERE UNABLE TO SPLIT THE DEVICE [FOR EXCHANGE]. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE RETURNED DEVICE WAS EVALUATED ON 01-AUG-2019 WAS FOUND TO HAVE 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 8918590 ↗
• MalfunctionAug 5, 2019Material Separation; Material Separation

  THIS CORRECTION FOLLOW UP REPORT IS BEING SENT TO CANCEL THE INITIAL REPORT SUBMITTED RELATED TO THIS EVENT. PLEASE REFERENCE THE SECTION H10 ADDITIONAL MANUFACTURER NARRATIVE FOR THIS JUSTIFICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8860451 ↗
• MalfunctionAug 2, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. THE ORIENTATION OF THE CUTTING WIRE SEEMS WRONG. THE CUTTING WIRE WAS PLACED NEXT TO THE CATHETER INSTEAD OF ABOVE [SIC] [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 8855200 ↗
• MalfunctionJul 25, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. WHEN THEY USED THE SPHINCTEROTOME FOR CANNULATION IN TO THE BILE DUCT, THE CATHETER TIP HAS BEEN ROTATED. THEY COULD NOT USE IT BECAUSE IT WAS TWISTED IN ITS DIRECTION [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 8828927 ↗
• MalfunctionJun 13, 2019Material Separation; Material Separation

  DURING A PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. THE USER FOUND THE SHEATH CRACKED AT THE TOP OF THE CUTTING WIRE [CATHETER SPLIT AT CUTTING WIRE] DURING USE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED ON 21-MAY-2019 AND THE EVALUATION DETERMINED THAT 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 8697110 ↗
• MalfunctionJun 13, 2019Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. WHEN THE USER BOWED UP THE CUTTING WIRE TO DO THE SPHINCTEROTOMY, THE ANCHOR [CUTTING WIRE SECURING COMPONENT] AT THE DISTAL END PULLED OUT OF THE CATHETER AND WAS STILL ATTACHED TO THE CUTTING WIRE. THE DEVICE WAS REMOVED AND THE PHYSICIAN USED ANOTHER TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. 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 8696705 ↗
• MalfunctionMay 24, 2019Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. THE CUTTING WIRE TIP WAS BROKEN DURING THE PROCEDURE. THE AREA AHEAD OF TIP OF CUTTING WIRE WAS CRACKED [CATHETER SPLIT AT CUTTING WIRE]. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 29-APR-2019 AND THE CUTTING WIRE SECURING COMPONENT WAS FOUND TO BE 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 8640358 ↗
• MalfunctionMay 17, 2019Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. THE WIRE [CATHETER] FROM THE SPHINCTEROTOME WAS FRAYED [DIFFICULT STRIPPING]. THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW SPHINCTEROTOME WAS OPENED. THERE WAS] NO INJURY TO THE PATIENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED ON 04/23/2019 AND THE EVALUATION DETERMINED 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 8620861 ↗
• MalfunctionMay 13, 2019Material Deformation; Material Deformation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. WHEN THE TIP CAME INTO VIEW IT WAS APPARENT THE DOME TIP WAS DAMAGED. UPON REMOVAL, IT WAS CONFIRMED THAT THE TIP FELT "SHARP", CONFIRMING OUR VISUAL SUSPICIONS. 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 8604343 ↗
• MalfunctionMay 10, 2019Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. THE CUTTING WIRE BROKE DURING PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 15-APR-2019 AND IT WAS DETERMINED THAT THE CUTTING WIRE SECURING COMPONENT HAD SEPARATED FROM THE SPHINCTEROTOME CATHETER AND A PORTION WAS MISSING. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER, THE LOCATION OF THE MISSING PORTION 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: No Consequences Or Impact To Patient

  MAUDE report 8601129 ↗