MicroKnife XL M00532810Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 08714729172017), received between Jul 18, 2017 and Sep 29, 2026 — classified as 12 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Break” (76 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 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Retraction Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941034 ↗
• MalfunctionMay 22, 2026Break; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON(B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE DEVICE, BUT AT ONE POINT THE METAL TIP FAILED TO EXTEND, PREVENTING THE INCISION FROM BEING MADE. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER UNIT 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE BROKE. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262929 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NEEDLE BROKE OFF INSIDE THE AMPULLA. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156227 ↗
• MalfunctionApr 1, 2026Break; Mechanical Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PERFORM A PRECUT USING A NEEDLE KNIFE. ALTHOUGH THE NEEDLE KNIFE WAS INSERTED THROUGH THE SCOPE, THE NEEDLE FAILED TO EXTEND FROM THE DEVICE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A DIFFERENT 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 GOOD. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE BROKE AND CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758871 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS PREPARED FOR USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY OBSTRUCTION PERFORMED ON (B)(6) 2026. DURING THE PREPARATION OUTSIDE THE PATIENT, IT WAS REPORTED THAT WHEN THE PRODUCT WAS UNPACKED AND IT WAS NOTICED THAT THE WIRE ON THE HANDLE WAS FRACTURED AND COULD NOT BE USED. 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 24706599 ↗
• MalfunctionMar 10, 2026Break; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE KNIFE WAS NOT DISPLAYED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF DEVICE CUTTING WIRE BROKEN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565008 ↗
• MalfunctionMar 2, 2026Deformation Due to Compressive Stress; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE 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, AFTER PASSING THE DEVICE THROUGH THE ENDOSCOPE CHANNEL AND MAKING THE INCISION, IT WAS NOT POSSIBLE TO REASSEMBLE THE NEEDLE. THE ENDOSCOPE WAS REMOVED FROM THE PATIENT WITH THE DEVICE BEFORE THE DEVICE WAS REMOVED FROM THE ENDOSCOPE. A PHOTO WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE NEEDLE WAS EXTENDED AND KINKED, AND THE TIP OF THE EXTRUSION WAS SPLIT. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490071 ↗
• MalfunctionMar 2, 2026Break; Mechanical Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PRE-CUT NEEDLE FAILED TO OPEN AFTER SEVERAL SUCCESSFUL OPENINGS AND CLOSINGS. ON APPROXIMATELY THE FOURTH OR FIFTH ATTEMPT, THE NEEDLE REMAINED CLOSED DESPITE THE NURSE POSITIONING IT IN THE OPEN STATE. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A CUTTING WIRE BROKEN AND KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489609 ↗
• MalfunctionJan 29, 2026Break; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE POWER SUPPLY WAS CONNECTED AND THE ELYTROTOMY WAS PREPARED, THE CUTTING WIRE OF THE TOME COULD NOT COME OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MICROKNIFE XL. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A CUTTING WIRE BREAK. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217828 ↗
• InjuryJan 7, 2026Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STENOSIS OF THE BILE DUCT PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE MICROKNIFE XL NEEDLE CUTTER BECAME LOOSE. IT WAS REPORTED THAT THE NEEDLE DETACHED AND FELL INSIDE THE PATIENT. THE DETACHED NEEDLE WAS SUCCESSFULLY RETRIEVED USING RESCUE RAT TOOTH / ALLIGATOR GRASPING FORCEPS. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A DIFFERENT 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 FULLY RECOVERED. NOTE: IT WAS REPORTED THAT THE DEVICE WAS ENERGIZED WHEN NOT IN CONTACT WITH TISSUE; HOWEVER, 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 23992246 ↗
• MalfunctionJan 5, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE DUODENAL AND PAPILLA PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE MICROKNIFE WAS INSERTED INTO THE DUODENAL SCOPE AND EXTENDED OUT OF THE WORKING CHANNEL, THEY NOTICED THAT THE KNIFE TIP WAS ALREADY BENT WHEN IT EMERGED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT 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 FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962181 ↗
• MalfunctionOct 22, 2025Mechanical Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THERE WAS NO POSSIBILITY OF EXTENDING THE NEEDLE. THE HANDLE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT AFTER THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364342 ↗
• MalfunctionOct 17, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WIRE DOES NOT COME OUT EVEN IF YOU PULL THE HANDLE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320215 ↗
• MalfunctionOct 6, 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 A MICROKNIFE XL WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE BEFORE ADVANCING INTO THE SCOPE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MICROKNIFE XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23228358 ↗
• MalfunctionSep 22, 2025Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING A SPHINCTEROTOMY PROCEDURE TO TREAT STONES IN THE BILE DUCTS PERFORMED ON (B)(6) 2025. DURING PREPARATION, AFTER OPENING THE PACKAGE AND TESTING THE NEEDLE EJECTION, IT WAS NOTICED THAT IT IS NOT POSSIBLE. A BROKEN WIRE IN THE HANDLE WAS FOUND. 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 23118761 ↗
• MalfunctionSep 8, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS ATTEMPTED TO BE USED IN THE LOWER GASTROINTESTINAL (GI) TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILIARY STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WIRE BROKE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, WHERE IT CAN BE OBSERVED THAT THE WIRE IN THE HANDLE SECTION WAS BROKEN AND KINKED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MICROKNIFE XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999319 ↗
• MalfunctionJul 15, 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 A MICROKNIFE XL WAS BEING PREPARED FOR USE IN THE AMPULLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED ON (B)(6) 2025. DURING PREPARATION OF DEVICE IN A PROCEDURE, IT WAS NOTICED THAT THE NEEDLE DID NOT CAME OUT AND THE METALLIC PIECE WAS BROKEN AT THE HANDLE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE CUSTOMER WHERE IT CAN BE OBSERVED THAT THE WIRE IN THE HANDLE SECTION WAS BROKEN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508888 ↗
• MalfunctionJun 11, 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 A MICROKNIFE XL WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, THE DEVICE WAS OPENED, AND NO PROBLEM WAS NOTED. THE DEVICE WAS ADVANCED THROUGH DUODENOSCOPE AND TRIED EXPOSING THE CUTTING WIRE, BUT IT WOULD NOT RESPOND. IT WAS THEN NOTICED THAT THE WIRE IN THE HANDLE BROKE. THE PROCEDURE WAS COMPLETED WITH A SECOND MICROKNIFE XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186169 ↗
• MalfunctionJun 5, 2025Break; Mechanical Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Break; Mechanical Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNFE XL WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE INNER SHEATH OF THE HANDLE BROKE AND THE NEEDLE DID NOT COME OUT. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUT WIRE BROKE. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150977 ↗
• InjuryApr 3, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL SPHINCTEROTOME WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NEEDLE FELL OUT OF THE DEVICE AND INTO THE PATIENT AFTER MINIMALLY TOUCHING THE MUCOSA. THE PROCEDURE WAS COMPLETED WITH ANOTHER MICROKNIFE XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21769687 ↗
• InjuryMar 31, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL SPHINCTEROTOME WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NEEDLE FELL OUT OF THE DEVICE AND INTO THE PATIENT AFTER MINIMALLY TOUCHING THE MUCOSA. THE PROCEDURE WAS COMPLETED WITH ANOTHER MICROKNIFE XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21734135 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS USED IN THE AMPULLA DURING A PAPILLOTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE TIP OF THE MICROKNIFE XL BROKE. IT WAS REPORTED THAT NO PART OF THE NEEDLE TIP 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 21682072 ↗
• InjuryMar 4, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE MICROKNIFE NEEDLE BROKE OFF INSIDE THE PATIENT TISSUE. A RAT TOOTH RETRIEVAL DEVICE WAS USED TO QUICKLY REMOVE THE DEVICE FRAGMENT. THE PROCEDURE WAS COMPLETED WITH A SECOND MICROKNIFE XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518713 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS USED IN THE PAPILLA OF VATER DURING A CHOLANGIOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS USED TO MAKE A CUT IN THE PAPILLA OF VATER AND THERE WAS NO PROBLEM ENCOUNTERED. THE PHYSICIAN REQUESTED TO KEEP THE TIP OF THE CUTTING NEEDLE TO FURTHER EXAMINE THE PAPILLA. AS THE PHYSICIAN ASK TO USE THE DEVICE AGAIN, THE DEVICE SHOWED RESISTANCE WHEN TRYING TO RETRACT THE TIP. AFTER SEVERAL ATTEMPTS AND DUE TO THE FORCE APPLIED, THE DEPLOYMENT SYSTEM WAS DAMAGED, AND THE TIP OF THE NEEDLE NEVER CAME OUT. IT WAS REPORTED THAT THE PULL WIRE AT THE HANDLE OF THE MICROKNIFE XL BROKE. 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 21454154 ↗
• MalfunctionFeb 5, 2025Break; Failure to Fold; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Break; Failure to Fold; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MICROKNIFE XL WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, WHEN THE DEVICE WAS OPENED AND TESTED, THE PHYSICIAN NOTED THAT THE TIP OF THE DEVICE DID NOT RESPOND ACCORDINGLY TO THE OPENING AND CLOSING MOVEMENT OF THE HANDLE. THE PHYSICIAN NOTED THAT THE METAL WIRE THAT CONNECTS THE HANDLE TO THE TIP OF THE DEVICE WAS BROKEN. THE DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315864 ↗