Autotome™ RX 39 M00545200Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 08714729444770), received between Dec 20, 2017 and Apr 17, 2026 — classified as 1 injury, 45 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE OF THE SPHINCTEROTOME BROKE OFF INSIDE THE PATIENT WHILE IT WAS IN USE. THE POSITION OF THE BROKEN PIECE INITIALLY PREVENTED THE PHYSICIAN FROM DEPLOYING A PANCREATIC STENT. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907113 ↗
• MalfunctionMar 20, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN SPHINCTEROTOMY WAS ATTEMPTED, THE CUT WIRE SNAPPED AND 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. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651547 ↗
• MalfunctionFeb 15, 2026Break; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE WIRE ANCHOR WAS DISLODGED FROM THE CATHETER UPON SPHINCTEROTOMY. IT WAS REPORTED THAT THE CUTTING WIRE WAS INTACT, AND 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 AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 12, 2026: IT WAS REPORTED THAT THERE WAS A BREAK IN THE CUTTING WIRE. THE ANATOMY LOCATION WAS THE AMPULLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341506 ↗
• MalfunctionFeb 13, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 39 BROKE OFF. 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 DUE TO 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 24332641 ↗
• MalfunctionOct 28, 2025Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 39 BROKE. A SECOND AUTOTOME WAS USED AND THE SAME PROBLEM OCCURRED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404265 ↗
• MalfunctionOct 28, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE CUTTING WIRE OF THE AUTOTOME RX 39 BROKE. A SECOND AUTOTOME WAS USED AND THE SAME PROBLEM OCCURRED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404244 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component

  DURING SPHINCTEROTOMY DR WAS USING THE TOME39 AND VIZI WIRE. UPON BOWING THE TOME AND ACTIVATING THE FOOT PEDAL, THE DISTAL END OF THE TOME BECAME DETACHED EXPOSING THE WIRE . IMMEDIATELY REMOVED AND REPLACED WITH SECOND TOME (SAME LOT) AND THE SAME ISSUE OCCURRED AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037113 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component

  DURING SPHINCTEROTOMY DR WAS USING THE TOME39 AND VIZI WIRE. UPON BOWING THE TOME AND ACTIVATING THE FOOT PEDAL, THE DISTAL END OF THE TOME BECAME DETACHED EXPOSING THE WIRE . IMMEDIATELY REMOVED AND REPLACED WITH SECOND TOME (SAME LOT) AND THE SAME ISSUE OCCURRED AGAIN. THIS REPORT IS FOR DEVICE #2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037063 ↗
• MalfunctionSep 10, 2025Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE PAPILLA DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE AUTOTOME OPENED AT THE LEVEL OF THE IRON LOOP, AND WHEN IT WAS TIME TO COAGULATE TO OPEN THE PAPILLA, THE IRON BAR BROKE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 18, 2025 THE TYPE OF PROCEDURE PERFORMED WAS ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). IT WAS REPORTED THAT THE CUTTING WIRE BROKE. NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IT WAS REPORTED THAT THE EXPOSED CUTTING WIRE WAS NOT FULLY EXITED THE ENDOSCOPE WHEN THE DEVICE WAS ENERGIZED; HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WARNING: VERIFY THAT THE CUTTING WIRE HAS EXITED THE ENDOSCOPE BY VISUALIZING IT ON THE ENDOSCOPE MONITOR. FAILURE TO DO SO MAY RESULT IN CONTACT BETWEEN THE CUTTING WIRE AND THE ENDOSCOPE WHILE ELECTRICAL CURRENT IS APPLIED. THIS MAY CAUSE GROUNDING, WHICH CAN RESULT IN PATIENT INJUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022540 ↗
• MalfunctionAug 11, 2025Break; Material Deformation; Break; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO AUTOTOME RX 39 USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE TOME INTO THE PAPILLA, AND UPON PRESSING THE FOOT PEDAL TO ACTIVATE THE CAUTERY, THE WIRE POPPED OFF ONE SIDE OF THE DEVICE BUT WAS STILL ATTACHED ON THE OTHER SIDE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE CUTTING WIRE WAS BROKEN AND KINKED. A SECOND DEVICE WAS ATTEMPTED BUT HAD THE SAME PROBLEM. THE PROCEDURE WAS COMPLETED WITH A THIRD AUTOTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779905 ↗
• MalfunctionAug 11, 2025Break; Material Deformation; Break; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO AUTOTOME RX 39 USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE TOME INTO THE PAPILLA, AND UPON PRESSING THE FOOT PEDAL TO ACTIVATE THE CAUTERY, THE WIRE POPPED OFF ONE SIDE OF THE DEVICE BUT WAS STILL ATTACHED ON THE OTHER SIDE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE CUTTING WIRE WAS BROKEN AND KINKED. A SECOND DEVICE WAS ATTEMPTED BUT HAD THE SAME PROBLEM. THE PROCEDURE WAS COMPLETED WITH A THIRD AUTOTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779900 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE SNAPPED DURING AN ATTEMPT TO PERFORM A SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398898 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE SNAPPED DURING AN ATTEMPT TO PERFORM A SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398595 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE SNAPPED DURING AN ATTEMPT TO PERFORM A SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398591 ↗
• MalfunctionJul 3, 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 AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE SNAPPED DURING AN ATTEMPT TO PERFORM A SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395742 ↗
• MalfunctionJul 3, 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 AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE SNAPPED DURING AN ATTEMPT TO PERFORM A SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395738 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE SNAPPED DURING AN ATTEMPT TO PERFORM A SPHINCTEROTOMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395737 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE AUTOTOME WAS INSERTED THROUGH THE SCOPE AND ADVANCED TO THE PAPILLA IN A NORMAL FASHION. THE AUTOTOME WAS ENGAGED INTO THE AMPULLA, THEN THE WIRE SNAPPED INSIDE THE COMMON BILE DUCT. THE AUTO TOME WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365876 ↗
• MalfunctionJun 7, 2025Failure to Fold; Device Contamination with Chemical or Other Material; Failure to Fold; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO FOUR AUTOTOME RX 39 USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, THE AUTOTOME WAS NOT BOWING AT THE DISTAL END OF THE DEVICE AND WAS INSTEAD BOWING NEAR THE HANDLE OF THE TOME. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 39. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWS A RUST LIKE MATERIAL IN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163156 ↗
• MalfunctionJun 7, 2025Failure to Fold; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Failure to Fold; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO FOUR AUTOTOME RX 39 USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, THE AUTOTOME WAS NOT BOWING AT THE DISTAL END OF THE DEVICE AND WAS INSTEAD BOWING NEAR THE HANDLE OF THE TOME. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 39. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWS A RUST LIKE MATERIAL IN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162609 ↗
• MalfunctionJun 7, 2025Failure to Fold; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Failure to Fold; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO FOUR AUTOTOME RX 39 USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, THE AUTOTOME WAS NOT BOWING AT THE DISTAL END OF THE DEVICE AND WAS INSTEAD BOWING NEAR THE HANDLE OF THE TOME. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 39. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWS A RUST LIKE MATERIAL IN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162504 ↗
• MalfunctionJun 7, 2025Failure to Fold; Device Contamination with Chemical or Other Material; Failure to Fold; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO FOUR AUTOTOME RX 39 USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, THE AUTOTOME WAS NOT BOWING AT THE DISTAL END OF THE DEVICE AND WAS INSTEAD BOWING NEAR THE HANDLE OF THE TOME. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 39. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWS A RUST LIKE MATERIAL IN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162492 ↗
• MalfunctionNov 26, 2024Failure to Conduct; Device Contamination with Chemical or Other Material; Failure to Conduct; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE CUTTING WIRE WOULD NOT CUT AND THE GUIDEWIRE INSIDE THE CATHETER LOOKED RUSTED AND BLACK. A PHOTO OF THE DEVICE WAS PROVIDED AND SHOWS A DISCOLORATION OF THE GUIDEWIRE IN THE WORKING LENGTH OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 39 DEVICE. THERE WERE NO PATENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777938 ↗
• MalfunctionNov 20, 2024

  TOME JAMS WHEN PUSHING THE WIRE - THE TOME IS BENT MORE THAN HALFWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733826 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX 39 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, UPON MAKING A CUT, THE CUTTING WIRE BROKE IN THE MIDDLE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678963 ↗