Ultratome XL M00535900Recalls & reported problems

Summary

The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 08714729103257), received between Nov 8, 2017 and Sep 24, 2026 — classified as 1 injury, 204 malfunctions.

The most frequently reported specific device problem is “Break” (154 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 205 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  It was reported to Boston Scientific Corporation that an Ultratome XL was attempted to be used in the duodenal papilla during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure to treat Lithiasis performed on (b)(6) 2026.During the procedure, the cutting wire was fractured after being energized. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. The patient condition following procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877093 ↗
• MalfunctionSep 18, 2026Failure to Align; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50822196 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308219 ↗
• MalfunctionAug 7, 2026Break; Failure to Conduct; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  It was reported to Boston Scientific Corporation that an Ultratome XL was used in the ampulla during an Endoscopic Retrograde Cholangiopancreatography (ERCP) to treat biliary stones performed on (b)(6) 2025.During the procedure, the device stopped passing current. The connections were checked and patient plate was readjusted but no energy got transferred. The procedure was completed with another of the same device.There were no reported patient complications as a result of this event.Note:This event has been deemed a reportable event based on the investigation finding of wire break and wire kinked. Please see Block H11 for full investigation details.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180112 ↗
• MalfunctionJul 9, 2026Deformation Due to Compressive Stress; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25774275 ↗
• MalfunctionJul 6, 2026Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE TIP WIRE AT THE FRONT OF THE KNIFE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE DEVICE WAS ENERGIZED WHEN NOT IN CONTACT WITH TISSUE. PER THE INSTRUCTIONS FOR USE (IFU), PRECAUTION: IT IS RECOMMENDED TO MAINTAIN DIRECT AND CONSTANT CONTACT WITH TISSUE WHEN APPLYING ELECTROCAUTERY CURRENT. FAILURE TO DO SO MAY RESULT IN BROKEN CUT WIRE, DAMAGE TO THE ENDOSCOPE AND/OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25721926 ↗
• MalfunctionJun 6, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALLSTONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE WAS BROKEN. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25419845 ↗
• MalfunctionMay 27, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CUTTING WIRE BROKE DURING THE INITIAL PAPILLA PRE-CUT, DESPITE THE ELECTROSURGICAL UNIT BEING SET TO THE MINIMUM LEVEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303128 ↗
• MalfunctionApr 24, 2026Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE DUODENAL PAPILLARY SPHINCTER DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE TO TREAT COMMON BILE DUCT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PATIENT UNDERWENT RESECTION OF A LESION AT THE DUODENAL PAPILLA. WHILE PERFORMING THE INCISION OF THE DUODENAL PAPILLARY SPHINCTER, THE CUTTING WIRE AT THE TIP OF THE DEVICE SUDDENLY BROKE, MAKING IT IMPOSSIBLE TO CONTINUE THE INCISION. THE PROCEDURE WAS PAUSED FOR 20 MINUTES TO ALLOW FOR DEVICE EXCHANGE, AFTER WHICH IT RESUMED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE DEVICE WAS ENERGIZED PRIOR TO BOWING AND THE DEVICE WAS ENERGIZED WHEN NOT IN CONTACT WITH TISSUE. "PER THE INSTRUCTIONS FOR USE (IFU), PRECAUTION: THE SPHINCTEROTOME DOES NOT NEED TO BE ENERGIZED PRIOR TO PERFORMING SPHINCTEROTOMY. ENERGIZING THE CUTTING WIRE PRIOR TO USE WILL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24976046 ↗
• MalfunctionApr 23, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973709 ↗
• MalfunctionApr 21, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS UNPACKED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT INTESTINAL OBSTRUCTION PERFORMED ON (B)(6) 2026. DURING UNPACKING, IT WAS NOTICED THAT THE CUTTING WIRE EXTENDED OUT. A PHOTO WAS PROVIDED FROM THE CUSTOMER SHOWING THAT THE CUTTING WIRE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942571 ↗
• MalfunctionApr 7, 2026Nonstandard Device; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, ONCE THE DEVICE WAS INSERTED INTO THE PATIENT, THE CUTTING WIRE DID NOT APPEAR ON THE DISPLAY. A VISUAL INSPECTION REVEALED NO ISSUES WITH THE DEVICE ITSELF, BUT THE ULTRASOUND IMAGE REMAINED UNRESPONSIVE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801153 ↗
• MalfunctionApr 6, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN CUTTING THE DUODENAL PAPILLA, THE CUTTING WIRE WAS FRACTURED. IT WAS REPORTED THAT THE CUTTING WIRE WAS INTACT, BUT THE WIRE ANCHOR DISLODGED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796022 ↗
• MalfunctionApr 6, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE ULTRATOME XL WAS USED TO CUT THE PAPILLA OPENING, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795937 ↗
• MalfunctionApr 2, 2026Crack; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE WIRE ANCHOR OF THE ULTRATOME XL WAS DISLODGED FROM THE CATHETER. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. ADDITIONALLY, PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT SHOWS THE DEVICE TIP WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767313 ↗
• MalfunctionFeb 24, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE WAS NOT COMING FROM BILE DUCT PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, AFTER OPENING THE DEVICE PACKAGE, THE PHYSICIAN NOTICED THE CUTTING WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431773 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT INTESTINAL OBSTRUCTION PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401761 ↗
• MalfunctionFeb 19, 2026Break; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION WHILE THE DEVICE WAS STILL OUTSIDE OF THE PATIENT, A PROBLEM WAS OBSERVED WITH THE CURVED PAPILLOTOME. SPECIFICALLY, THE WIRE LOCATED AT THE TIP BROKE WHEN THE DEVICE WAS INSERTED INTO THE EQUIPMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397435 ↗
• MalfunctionFeb 2, 2026Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT PANCREATITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE WAS BROKE. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THE COMPLAINANT REPORTED THAT THE DEVICE WAS ENERGIZED PRIOR TO BOWING; HOWEVER, PER THE INSTRUCTIONS FOR USE (IFU), PRECAUTION: THE SPHINCTEROTOME DOES NOT NEED TO BE ENERGIZED PRIOR TO PERFORMING SPHINCTEROTOMY. ENERGIZING THE CUTTING WIRE PRIOR TO USE WILL CAUSE PREMATURE CUTTING WIRE FATIGUE AND WILL COMPROMISE THE CUTTING WIRE'S INTEGRITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234485 ↗
• MalfunctionFeb 2, 2026Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE WAS BROKE. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THE COMPLAINANT REPORTED THAT THE DEVICE WAS ENERGIZED PRIOR TO BOWING; HOWEVER, PER THE INSTRUCTIONS FOR USE (IFU), PRECAUTION: THE SPHINCTEROTOME DOES NOT NEED TO BE ENERGIZED PRIOR TO PERFORMING SPHINCTEROTOMY. ENERGIZING THE CUTTING WIRE PRIOR TO USE WILL CAUSE PREMATURE CUTTING WIRE FATIGUE AND WILL COMPROMISE THE CUTTING WIRE'S INTEGRITY. ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 10,2026. IT WAS REPORTED THAT THE DEVICE WAS NOT ENERGIZED PRIOR TO BOWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234176 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AT THE MOMENT OF INSERTING THE DEVICE INTO THE MAJOR PAPILLA, THE ERBE EQUIPMENT WAS ACTIVATED TO GENERATE THE CUT, INITIATING THE PAPILLOTOMY. AT THAT POINT, THE PAPILLOTOME ARCH RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885725 ↗
• MalfunctionDec 18, 2025Failure to Fold; Deformation Due to Compressive Stress; Failure to Fold; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE DID NOT BOW AT THE TIME OF CUTTING. IT WAS REPORTED THAT THE CUTTING WIRE APPEARED DEFORM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE CUSTOMER AND SHOWS THE CUTTING WIRE KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23845351 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE BILIARY SYSTEM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PRE-PROCEDURE, THE CUTTING WIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493900 ↗
• MalfunctionOct 21, 2025Break; Difficult to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TOME WAS DIFFICULT TO ADVANCE THROUGH THE SCOPE, AND THE HANDLE WAS BROKEN. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED WHERE IT CAN BE OBSERVED THAT THE HANDLE WAS BROKEN AND THE WIRE WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRATOME XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348577 ↗
• MalfunctionOct 16, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRATOME XL WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT INTESTINAL OBSTRUCTION PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE ULTRATOME XL BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23313978 ↗