Jagtome RX 39 M00573100Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729776536), received between Apr 9, 2018 and May 22, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 22, 2021Class IIOpen, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0770-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS PREPARED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALL STONES PERFORMED ON (B)(6) 2026. DURING PREPARATION, THE PHYSICIAN INSPECTED THE TOME AND NOTED THAT THE WIRE WAS EXCESSIVELY BENT. THE NURSE ATTEMPTED TO OPEN THE HANDLE TO ADJUST THE TOME, BUT THE WIRE COULD NOT BE STRAIGHTENED FURTHER. THE CUSTOMER PROVIDED A PICTURE WHERE IT WAS POSSIBLE TO OBSERVE THE DEVICE WAS ON A SEMI BOWED STATE. 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 25251476 ↗
• MalfunctionDec 26, 2025Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE DUODENUM AND AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR BILE DUCT ASSESSMENT PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED CANNULATION USING THE DEVICE. THE TOME APPEARED BOWED, AND THE PHYSICIAN INSTRUCTED THE NURSE TO FULLY OPEN THE HANDLE. DESPITE THIS, THE DEVICE REMAINED ENGAGED. THE TOME WAS SUBSEQUENTLY REMOVED, AND INSPECTION REVEALED THAT THE CUT WIRE WAS PARTIALLY BOWED AND COULD NOT STRAIGHTEN EVEN WITH THE HANDLE FULLY OPENED. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897937 ↗
• MalfunctionDec 24, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) AND PANCREATIC DUCT (PD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH MAC SEDATION FOR PANCREATIC MASS AND BILIARY OBSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE COMMON BILE DUCT AND PANCREATIC DUCT WERE CANNULATED WITH GUIDEWIRE, CHOLANGIOGRAM PERFORMED AND THEN SPHINCTEROTOMY PERFORMED. DURING SPHINCTEROTOMY, IT WAS NOTED THAT ONE END OF THE CUTTING WIRE ON THE SPHINCTEROTOME HAD BECOME DETACHED. THE TOME WAS IMMEDIATELY REMOVED THROUGH THE SCOPE. AT THIS POINT, THE DOCTOR WAS SATISFIED WITH THE EXTENT OF THE SPHINCTEROTOMY, SO NO NEW TOME WAS REQUIRED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CONTINUED WITH ADDITIONAL CHOLANGIOGRAM, BALLOON SWEEPS AND STENT PLACEMENT. BLEEDING FROM MOUTH NOTED DURING THE PROCEDURE. ANESTHESIA EVALUATED AND DETERMINED THE PATIENT TO BE STABLE WITH NO VENTILATION IMPAIRMENT, SO ERCP WAS COMPLETED. POST ERCP AN ESOPHAGOGASTRODUODENOSCOPY (EGD) SCOPE WAS REINTRODUCED TO EVALUATE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889193 ↗
• MalfunctionFeb 22, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE JAGTOME RX 39 WOULD NOT BOW. THE HANDLE LOOKED FINE AND MULTIPLE TACTICS WERE TRIED TO GET IT BOWED, AND THEN IT WAS NOTICED THAT THE CUTTING WIRE WAS ALREADY BROKEN, THAT'S WHY IT DID NOT BOW. 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. NOTE: NOTE: IT WAS REPORTED THAT THE DEVICE 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." ADDITIONALLY, THE DEVICE ENERGIZED WHEN NOT IN CONTACT WITH TISSUE; HOWEVER, PER THE IFU, "PRECAUTION: IT IS RECOMMENDED TO MAINTAIN DIRECT AND CONSTANT CONTACT WITH TISSUE WHEN APPLYING ELECTROCAUTERY CURRENT. FAILURE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757556 ↗
• MalfunctionMay 25, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS INTENDED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. UPON DELIVERY, IT WAS NOTICED THAT THE PACKAGING OF THE JAGTOME RX 39 WAS RIPPED AND THERE WAS A HOLE, COMPROMISING THE STERILE BARRIER. 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 17007056 ↗
• MalfunctionJan 8, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE METAL WIRE WAS DETACHED AT ONE END. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11139767 ↗
• MalfunctionNov 24, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE LIVER AND PANCREAS ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE SPHINCTEROTOMY WAS BEING PERFORMED, THE CUTTING WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10896795 ↗
• MalfunctionNov 13, 2019Break; Failure to Conduct; Break; Failure to Conduct

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER ADVANCING THE TOME THROUGH THE SCOPE TO THE AMPULLA, SPHINCTEROTOMY WAS INITIATED WITH A SMALL CUT. WHEN THE PHYSICIAN ATTEMPTED TO CONTINUE THE SPHINCTEROTOMY, THE CUTTING WIRE WAS UNABLE TO CONDUCT. IT WAS THEN NOTICED THAT THE CUTTING WIRE BROKE AT THE POXIMAL END; HOWEVER, THE DISTAL END WAS STILL ATTACHED. REPORTEDLY, NO PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A JAGTOME RX 44, USING THE SAME GENERATOR AND ACTIVE CORD. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9316739 ↗
• MalfunctionAug 9, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUTTING WIRE BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8878710 ↗
• MalfunctionJul 9, 2019Break; Break

  BOSTON SCIENTIFIC RECEIVED A JAGTOME RX 39 DEVICE WITH NO ASSOCIATED INFORMATION. EVALUATION OF THE DEVICE REVEALED A BROKEN CUTTING WIRE. FOLLOW UP WITH THE SENDER REVEALED THAT THIS JAGTOME RX 39 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THEY WERE TRYING TO INCREASE THE SIZE OF THE SPHINCTEROTOMY, AND THE PATIENT ALREADY HAD A METAL STENT IN PLACE. POSSIBLY, THE CUT WIRE TOUCHED THE METAL STENT AND BROKE AT THAT POINT. REPORTEDLY, NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO FURTHER ACTION NEEDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773772 ↗
• MalfunctionJun 6, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JAGTOME WAS USED AND CANNULATION WAS ACHIEVED SUCCESSFULLY. A METAL STENT WAS THEN PLACED; HOWEVER, THE PHYSICIAN DECIDED TO ENLARGE THE AMPULLA, SO THE PHYSICIAN RE-INTRODUCED THE JAGTOME. CAUTERY WAS APPLIED, AND THEN IT WAS NOTICED THAT THE CUTTING WIRE BROKE. REPORTEDLY, THERE WAS NO ISSUE WITH THE METAL STENT. AFTER THE CUTTING WIRE BROKE, THEY DECIDED THAT NO FURTHER ACTION WAS NEEDED, AND THE PROCEDURE WAS ENDED. THERE WAS NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE END OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674581 ↗
• MalfunctionApr 16, 2019Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE TOME WAS BOWED, IT FAILED TO RETURN TO THE UNBOWED POSITION. ADDITIONALLY, IT WAS REPORTED THAT WHEN BOWED, THE TOME WAS NOT BOWING IN THE INTENDED PLANE. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8518068 ↗
• InjuryFeb 27, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT JAGTOME RX 39 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WENT TO PERFORM SPHINCTEROTOMY, IT WAS NOTICED THAT THE CUTTING WIRE BROKE OFF. THE DETACHED PART WAS RETRIEVED FROM THE PATIENT USING A RAT TOOTH FORCEPS. REPORTEDLY, THE PATIENT HAD A JOLT REFLEX AND HAD FELT SOME ELECTRIC CURRENT SHOCK WHEN THE WIRE BROKE OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, USING THE SAME GENERATOR AND ACTIVE CORD. THE PATIENT'S CONDITION AT THE END OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: Electric Shock

  MAUDE report 8373785 ↗
• MalfunctionDec 26, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE RECTUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE CUTTING WIRE WAS BROKEN AT THE DISTAL TIP. REPORTEDLY, THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME RX 39. 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 Consequences Or Impact To Patient

  MAUDE report 8197934 ↗
• MalfunctionDec 20, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUT WIRE DETACHED FROM THE DISTAL TIP. THERE WERE NO INJURY NOR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8188266 ↗
• MalfunctionOct 18, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER BOWING THE DEVICE A FEW TIMES, THE CUTTING WIRE BROKE. REPORTEDLY, NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND JAGTOME RX 39, USING THE SAME GENERATOR AND ACTIVE CORD USED. THERE WERE NO USER INJURIES NOR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7979193 ↗
• MalfunctionOct 5, 2018Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES WHICH WERE UNPACKED DURING THE SAME EVENT. REFER TO MFR REPORT# 3005099803-2018-60721 FOR THE FIRST JAGTOME AND MFR REPORT# 3005099803-2018-60722 FOR THE SECOND JAGTOME. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, IT WAS NOTICED THAT TWO JAGTOME PACKAGES HAD HOLES AND WAS CONFIRMED THAT THE STERILE BARRIER WAS COMPROMISED. REPORTEDLY, THERE WAS NO PATIENT NOR PROCEDURE INVOLVED IN THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7938908 ↗
• MalfunctionOct 5, 2018Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES WHICH WERE UNPACKED DURING THE SAME EVENT. REFER TO MFR REPORT# 3005099803-2018-60721 FOR THE FIRST JAGTOME AND MFR REPORT# 3005099803-2018-60722 FOR THE SECOND JAGTOME. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, IT WAS NOTICED THAT TWO JAGTOME PACKAGES HAD HOLES AND WAS CONFIRMED THAT THE STERILE BARRIER WAS COMPROMISED. REPORTEDLY, THERE WAS NO PATIENT NOR PROCEDURE INVOLVED IN THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7938893 ↗
• MalfunctionApr 9, 2018Failure to Align; Failure to Align

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME¿ RX 39 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED. THE EXACT PROCEDURE DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE CASE WAS PERFORMED SOMETIME IN THE SECOND WEEK OF (B)(6). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TOME WOULD NOT RELAX FROM THE BOWED POSITION REGARDLESS OF THE EFFORT OF MANIPULATING THE HANDLE. THEY LEFT THE GUIDEWIRE IN PLACE AND JUST REMOVED THE SPHINCTEROTOME. THEY THEN LOADED A 9MM-12MM EXTRACTOR BALLOON AND COMPLETED THE PROCEDURE. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7406408 ↗