Single Use 3-Lumen Sphincterotome V KD-V411M-0720 (UDI 04953170382628)Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 04953170382628), received between May 30, 2019 and Jan 30, 2025 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Break” (58 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 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED WHEN THE SUBJECT DEVICE FIRST BOX WAS OPENED, THE KNIFE WAS BROKEN, AND WHEN THE SECOND BOX WAS OPENED, THE KNIFE WAS ALSO BROKEN. THE THIRD ONE WAS FINALLY USED NORMALLY. THE ISSUE OCCURRED DURING SEDATION FOR AN UNKNOWN THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETE WITH AN OLYMPUS BACK UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274158 ↗
• MalfunctionJan 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, THE SUBJECT DEVICE'S KNIFE WIRE WAS BROKEN WHEN FIRST ENERGIZED. THE BROKE OFF INSIDE THE PATIENT'S BODY AND DID NOT FALL OFF. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207601 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE'S CUTTING WIRE WAS BROKEN AND SPARKS OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113489 ↗
• MalfunctionOct 31, 2024Break; Break

  IT WAS REPORTED THAT THE KNIFE WIRE OF THE SPHINCTEROTOME BROKE WHEN ELECTRICITY WAS APPLIED DURING NIPPLE INCISION. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE AND THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577500 ↗
• MalfunctionOct 29, 2024Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE'S KNIFE WIRE BROKE. THE ISSUE OCCURRED AT THE END OF AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559444 ↗
• MalfunctionOct 23, 2024Break; Thermal Decomposition of Device; Material Split, Cut or Torn; Break; Thermal Decomposition of Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A BILIARY ENDOSCOPIC SPHINCTEROTOMY (EST) THERAPEUTIC PROCEDURE THE WIRE BROKE WHILE ELECTRICITY WAS BEING APPLIED ON THE SINGLE-USE 3-LUMEN SPHINCTEROTOME. THE PROCEDURE WAS COMPLETED BY SWITCHING TO A SIMILAR PRODUCT. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515893 ↗
• MalfunctionOct 14, 2024Break; Break

  IT WAS REPORTED THAT THE KNIFE WIRE OF THE SINGLE-USE 2-LUMEN SPHINCTEROTOME WAS BROKEN. THE ISSUE OCCURRED DURING CANNULATION IN AN ENDOSCOPIC SPHINCTEROTOMY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447947 ↗
• MalfunctionOct 14, 2024Break; Break

  IT WAS REPORTED THAT DURING ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY), WHEN TRYING TO OUTPUT USING THE SINGLE USE 3-LUMEN SPHINCTEROTOME V, THE KNIFE WIRE BROKE. THE DOCTOR REPLACED IT WITH ANOTHER PRODUCT OF THE SAME MODEL NUMBER AND COMPLETED THE PROCEDURE. NO PART FELL OUT OF THE BODY. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447851 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED THE SPHINCTEROTOME V EXPERIENCED THE KNIFE WIRE BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC EXERCISE STRESS TEST (EST). THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251684 ↗
• MalfunctionSep 9, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED, THE SPHINCTEROTOME V EXPERIENCED PEELING OF THE INSULATING COATING WIRE. THE ISSUE OCCURRED, DURING A THERAPEUTIC EXTRACORPOREAL SHOCKWAVE THERAPY (EST) PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20174546 ↗
• MalfunctionSep 6, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT TWO SINGLE USE 3 LUMEN SPHINCTEROTOMES HAD KNIFE WIRES WITH PEELED OFF COATING. THE FIRST HAD A WIRE WITH SLIGHT PEELING OF THE INSULATING COATING, AND THE SECOND HAD A WIRE THAT HAD NO COATING LEFT. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SECOND DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158866 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THE 3-LUMEN SPHINCTEROTOME V KNIFE BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213828 ↗
• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY CASE, THE SPHINCTEROTOME WIRE BROKE WHEN TISSUE WAS REMOVED WHILE ELECTRICITY WAS BEING APPLIED. THE PROCEDURE WAS COMPLETED AFTER SWITCHING TO ANOTHER OF THE SAME PRODUCT. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19198717 ↗
• MalfunctionMar 18, 2024Break; Sparking; Break; Sparking

  IT WAS REPORTED, THE WIRE NEAR THE COVERING OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS BROKEN. THE ISSUE HAPPENED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926505 ↗
• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED THAT AFTER INSERTING THE SPHINCTEROTOME INTO THE DUODENAL PAPILLA, A KNIFE WAS STRETCHED AND ELECTRICITY WAS APPLIED, AND AFTER MULTIPLE INCISIONS OF THE DUODENAL PAPILLA, THE FRONT PART OF THE INSULATOR BROKE. SINCE THE DUODENAL PAPILLARY INCISION HAD BEEN COMPLETED, IT WAS REMOVED, AND THE PROCEDURE CONTINUED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882943 ↗
• MalfunctionFeb 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED WIRE OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS BROKEN. THE CUTTING WIRE THAT ENABLED THE TIP OF THE DEVICE TO BEND WAS BROKEN AND THE CUSTOMER COULD NOT GET THE TIP TO BEND WHEN TESTING IT. THE ISSUE OCCURRED AFTER OPENING THE DEVICE PACKAGE PRIOR TO A THERAPEUTIC PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719848 ↗
• MalfunctionFeb 11, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE BROKE WHILE APPLYING ELECTRICITY DURING THE NIPPLE INCISION IN A THERAPEUTIC PAPILLOTOMY PROCEDURE. NO PARTS FELL OFF. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAYS. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682863 ↗
• MalfunctionJan 24, 2024Break; Melted; Material Split, Cut or Torn; Break; Melted; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY THE KNIFE WIRE OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME V BROKE WHEN IT WAS ENERGIZED. THE CUSTOMER REPORTED THERE WAS NO SHEDDING INSIDE THE PATIENT¿S BODY. THE HIGH FREQUENCY EQUIPMENT AND SETTINGS USED WERE NOT SPECIFIED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570477 ↗
• MalfunctionJan 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME HAD SOMETHING LIKE A THREAD ATTACHED TO THE KNIFE. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569896 ↗
• MalfunctionJan 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE WIRE OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS DISCONNECTED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534947 ↗
• MalfunctionJan 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE WIRE COATING OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME PEELED OFF WHEN THE PACKAGE WAS OPEN. THE ISSUE OCCURRED DURING PRE-USE INSPECTION. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534374 ↗
• MalfunctionJan 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE POWER OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS NOT TURNED DURING THE FIRST USE WHEN USED WITH AN ELECTROSURGICAL UNIT. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THERE WERE NO ABNORMALITIES IN THE APPEARANCE OF THE KNIFE WIRE. ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533928 ↗
• MalfunctionJan 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE INSULATING COATING OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS PEELED OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533443 ↗
• MalfunctionJan 18, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED THE PLASTIC PART AT THE TIP OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS BEND AND DAMAGED. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE AFTER THE DEVICE WAS INSERTED INTO THE FORCEPS CHANNEL OF A SCOPE AND CAME OUT OF THE SCOPE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533209 ↗
• MalfunctionJan 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE INSULATING COATING OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS WORN OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533054 ↗