Single Use 3-Lumen Sphincterotome V KD-V411M-1520 (UDI 04953170382659)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170382659), received between Dec 23, 2021 and Oct 9, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Break; Thermal Decomposition of Device; Material Split, Cut or Torn; Break; Thermal Decomposition of Device; Material Split, Cut or Torn

  ADDITIONAL INFORMATION: THE INTENDED PROCEDURE WAS PART OF AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, AND NO PART FELL OFF. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413023 ↗
• MalfunctionAug 8, 2024Break; Sparking; Break; Sparking

  IT WAS REPORTED, THAT THE KNIFE WIRE BROKE. WHEN THE KD-V411M-1520 (SPHINCTEROTOME) WAS ENERGIZED. THE ISSUE OCCURRED, DURING AN THERAPEUTIC PROCEDURE. AND THE PROCEDURE WAS COMPLETED USING THE SIMILAR SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945606 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED DURING THE PROCEDURE, THE KNIFE WIRE OF THE LUMEN SPHINCTEROTOME WAS NOT FACING IN THE 11-CLOCK DIRECTION AND BROKE AFTER ELECTRICITY WAS APPLIED. THE UNSPECIFIED DIAGNOSTIC PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911037 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE WAS BROKEN. THE ISSUE OCCURRED DURING PREPARATION FOR USE, AND THE UNSPECIFIED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720522 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE 3-LUMEN SPHINCTEROTOME KNIFE WIRE BROKE. THE ISSUE OCCURRED DURING THE PROCEDURE. THE PRODUCT WAS SWITCHED OUT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18749232 ↗
• MalfunctionJan 19, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THAT DURING PREPARATION FOR USE, THE KNIFE WIRE OF THE SINGLE USE 2-LUMEN SPHINCTEROTOME WAS BENT FROM THE BEGINNING, SO IT COULD NOT BE USED FOR THE PROCEDURE. THE THERAPEUTIC PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543210 ↗
• MalfunctionMar 10, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THAT DURING A THERAPEUTIC FOR AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE BROKE. IT IS NOT KNOWN WHETHER OR NOT THE BREAK OCCURRED AT THE TIME OF OUTPUT. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THIS FAILURE OCCURRED MULTIPLE TIMES. THE DEVICE WAS INSPECTED BEFORE USE AND THERE WERE NO ABNORMALITIES FOUND. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526077 ↗
• MalfunctionMar 10, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THAT DURING A THERAPEUTIC FOR AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE BROKE. IT IS NOT KNOWN WHETHER OR NOT THE BREAK OCCURRED AT THE TIME OF OUTPUT. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THIS FAILURE OCCURRED MULTIPLE TIMES. THE DEVICE WAS INSPECTED BEFORE USE AND THERE WERE NO ABNORMALITIES FOUND. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526018 ↗
• MalfunctionDec 18, 2022Break; Melted; Break; Melted

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, DURING A THERAPEUTIC DUODENAL PAPILLOTOMY ENDOSCOPIC SPHINCTEROTOMY (EST) THE KNIFE WIRE TIP (SINGLE USE 3-LUMEN SPHINCTEROTOME V) CUT AND POPPED OUT. THE POWER STATUS IS UNKNOWN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16001484 ↗
• MalfunctionDec 17, 2022Break; Melted; Break; Melted

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, DURING A THERAPEUTIC DUODENAL PAPILLOTOMY ENDOSCOPIC SPHINCTEROTOMY (EST) THE KNIFE WIRE (SINGLE USE 3-LUMEN SPHINCTEROTOME V) BROKE. THE ENERGIZATION STATUS IS UNKNOWN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16001438 ↗
• MalfunctionDec 27, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE DISTRIBUTOR THAT DURING A PROCEDURE USING THE SUBJECT DEVICE, THE FOLLOWING EVENT OCCURRED. THE USER TRIED TO STRAIN A KNIFE WIRE IN FRONT OF THE PAPILLA OF VATER AND IT BROKE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE CUTTING WIRE WAS BROKEN AND THAT THE BROKEN PORTION WAS SCORCHED AND MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090902 ↗
• MalfunctionDec 23, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE FOLLOWING REPORT FROM THE NON-HEALTHCARE PROFESSIONAL. DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE END OF THE SUBJECT DEVICE BROKE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OMSC FOUND THAT THE CUTTING WIRE WAS BROKEN OFF ON THE ACTIVATION. THIS IS THE REPORT REGARDING THE CUTTING WIRE THAT WAS BROKEN OFF ON THE ACTIVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13074258 ↗