Single Use Preloaded Sphincterotome V KD-V611M-07301S (REF N5787030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170403125), received between Mar 10, 2022 and Nov 9, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE PRELOADED SPHINCTEROTOME WIRE BROKE WHEN THE CAUTERY WAS APPLIED FOR THE SECOND CUT. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108073 ↗
• MalfunctionJul 22, 2022Break; Break

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC SPHINCTEROTOMY PROCEDURE, THE KNIFE WIRE BROKE WHEN IT WAS BOWED AND CAUTERY WAS APPLIED. THE DEVICE WAS HALF-BOWED AT THE TIME, AND IT OCCURRED DURING THE THIRD TIME THAT CAUTERY WAS APPLIED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED ISSUE. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089354 ↗
• MalfunctionMar 10, 2022Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING CUT OF THE PAPILLA AT THE 2ND TIMES USING THE SUBJECT DEVICE, THE CUTTING WIRE WAS BROKEN OFF AND THE INSULATION WAS ALSO MISSING. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER REPORTED THAT THE OTHER 4 PRODUCTS ALSO WAS BROKEN OFF AND THE INSULATION WAS MISSING FROM THE LAST FEW WEEKS. THIS IS THE 5TH REPORT OF FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13718510 ↗
• MalfunctionMar 10, 2022Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING CUT OF THE PAPILLA AT THE 2ND TIMES USING THE SUBJECT DEVICE, THE CUTTING WIRE WAS BROKEN OFF AND THE INSULATION WAS ALSO MISSING. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER REPORTED THAT THE OTHER 4 PRODUCTS ALSO WAS BROKEN OFF AND THE INSULATION WAS MISSING FROM THE LAST FEW WEEKS. THIS IS THE FOURTH REPORT OF FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13718472 ↗
• MalfunctionMar 10, 2022Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING CUT OF THE PAPILLA AT THE 2ND TIMES USING THE SUBJECT DEVICE, THE CUTTING WIRE WAS BROKEN OFF AND THE INSULATION WAS ALSO MISSING. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER REPORTED THAT THE OTHER 4 PRODUCTS ALSO WAS BROKEN OFF AND THE INSULATION WAS MISSING FROM THE LAST FEW WEEKS. THIS IS THE THIRD REPORT OF FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13718436 ↗
• MalfunctionMar 10, 2022Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING CUT OF THE PAPILLA AT THE 2ND TIMES USING THE SUBJECT DEVICE, THE CUTTING WIRE WAS BROKEN OFF AND THE INSULATION WAS ALSO MISSING. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER REPORTED THAT THE OTHER 4 PRODUCTS ALSO WAS BROKEN OFF AND THE INSULATION WAS MISSING FROM THE LAST FEW WEEKS. THIS IS THE SECOND REPORT OF FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13718403 ↗
• MalfunctionMar 10, 2022Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING CUT OF THE PAPILLA AT THE 2ND TIMES USING THE SUBJECT DEVICE, THE CUTTING WIRE WAS BROKEN OFF AND THE INSULATION WAS ALSO MISSING. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER REPORTED THAT THE OTHER 4 PRODUCTS ALSO WAS BROKEN OFF AND THE INSULATION WAS MISSING FROM THE LAST FEW WEEKS. THIS IS THE FIRST REPORT OF FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13718260 ↗