Single Use Preloaded Sphincterotome V KD-V611M-07251SRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04953170403088), received between Jul 21, 2022 and Mar 11, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Break; Material Fragmentation

  IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME CUTTING WIRE RUPTURED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24572067 ↗
• MalfunctionMar 11, 2026Break; Material Fragmentation

  IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME NEEDLE CUTTING WIRE RUPTURED DURING INCISION. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24572002 ↗
• MalfunctionJan 30, 2026Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223729 ↗
• MalfunctionJan 30, 2026Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223637 ↗
• MalfunctionJan 30, 2026Break; Material Fragmentation

  IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME HAD A BROKEN WIRE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223573 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421542 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21416442 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21416208 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21416013 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415402 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415381 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415364 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415319 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415300 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415270 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415203 ↗
• MalfunctionSep 20, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE SPHINCTEROTOME INSULATION DETACHES FROM THE CUTTING WIRE. THE ISSUE OCCURRED DURING THERAPEUTIC ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273863 ↗
• MalfunctionJul 21, 2022Break; Break

  AS REPORTED, WITHIN A SHORT TIME, THE WIRE BROKE ON THREE PAPILOTOMES DEVICE (KD-V611M-07251S, BATCH LOT 11V). ACCORDING TO THE CUSTOMER WITHOUT MUCH EFFORT ON THE HANDPIECE, THERE IS NO INJURY TO THE PATIENT. ACCORDING TO THE REPORT, FOR THE FIRST TWO DEVICE, THE CUSTOMER DID NOT CONTACTED OLYMPUS AND DISPOSED THE DEFECTIVE DEVICE. THE OTHER DEFECTIVE DEVICE (THIRD DEVICE) WAS KEPT AND RETURNED TO OLYMPUS FOR EVALUATION. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. EVALUATION OF THE RETURNED DEVICE FOUND THE CUTTING WIRE WAS TORN, BROKEN AND NOTED MELTED AND SCORCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080650 ↗