Single Use 3-Lumen Sphincterotome V KD-V431M-0730 (UDI 04953170184192)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170184192), received between Jan 7, 2019 and Feb 24, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CUTTING WIRE OF THE DEVICE WAS BROKEN AT THE PROXIMAL END SITE. THERE WAS NO REPORT OF HARM, NOR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. IT WAS FURTHER OBSERVED AFTER THE PROCEDURE, DURING INSPECTION OF THE DEVICE, THAT THE COATED PORTION OF THE CUTTING WIRE WAS TORN, AND THE BROKEN PORTION WAS MELTED AT THE PROXIMAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447642 ↗
• MalfunctionOct 22, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SPHINCTEROTOME EXHIBITED THE COVER WAS PEELED, AND THE KNIFE WAS EXPOSED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20511515 ↗
• MalfunctionSep 10, 2024Material Separation; Material Separation

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE SPHINCTEROTOME EXHIBITED THE COVER WAS PEELED AND THE KNIFE WAS EXPOSED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185575 ↗
• MalfunctionNov 29, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V HAD A WIRE BREAK DURING AN UNSPECIFIED ERCP PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE AND NO REPORTS OF PATIENT OR USER HARM WERE ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230212 ↗
• MalfunctionSep 12, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V HAD A BROKEN WIRE. THE ISSUE WAS FOUND DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) 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 17732888 ↗
• MalfunctionJan 18, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THE SUBJECT DEVICE CUTTING WIRE BROKE DURING AN UNKNOWN PROCEDURE. THE SUBJECT DEVICE WAS BEING USED WITH A FUJI ENDOSCOPE AND AN ERBE GENERATOR. THE CUTTING WIRE APPEARED BURNT WHERE IT BROKE AND THE CATHETER DISLODGED FROM THE CATHETER. A NON-OLYMPUS SPHINCTEROTOME WAS USED TO COMPLETE THE PROCEDURE. THE CUSTOMER REPORTED NO PATIENT INJURY OR HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13283117 ↗
• MalfunctionFeb 26, 2021Break; Break

  WE RECEIVED THE FOLLOWING REPORT FROM THE HEALTH PROFESSIONAL. DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST), THE SUBJECT DEVICE WAS USED. THE BLADE OF THE SUBJECT DEVICE BROKE AFTER ACTIVATING THE OUTPUT SEVERAL TIMES (TOWARDS THE END OF THE PROCEDURE). THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. A PHOTO OF THE SUBJECT DEVICE WAS PROVIDED AND BROKEN KNIFE WIRE WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11383409 ↗
• MalfunctionJan 7, 2019Break; Break

  DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE CUTTING WIRE WAS BROKEN. NO PATIENT INJURY WAS REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEM CORP. (OMSC) FOR EVALUATION. ON DECEMBER 28, 2018, IT WAS CONFIRMED THAT THE COATING ON THE CUTTING WIRE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE MISSING OF THE CUTTING WIRE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8221255 ↗