Single Use 3-Lumen Sphincterotome V KD-V411M-1530 (UDI 04953170382666)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04953170382666), received between Nov 23, 2021 and Oct 1, 2024 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY SURGERY, WHEN INSERTING THE SPHINCTEROTOME INTO THE ENDOSCOPE, THE DOCTOR NOTICED THAT THE KNIFE WIRE WAS FACING IN A DIFFERENT DIRECTION THAN USUAL. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344467 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE'S KNIFE WIRE WAS BROKEN. THE ISSUE OCCURRED DURING A PROCEDURE THAT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145591 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT THE LUMEN SPHINCTEROTOME HAD A BREAK. THE ISSUE OCCURRED DURING AN ENDOSCOPIC THORACIC SYMPATHECTOMY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974331 ↗
• MalfunctionJul 8, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THE SPHINCTEROTOME EXPERIENCED THE WIRE BROKE WHEN TENSIONING THE KNIFE WIRE. THE FIRST TIME IT CUT NORMALLY, AND THE SECOND TIME IT WAS TENSIONED. THE BREAK HAPPENED WHEN ELECTRICITY WAS NOT BEING APPLIED. IT DID NOT FALL OUT IN THE BODY. 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 19695923 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED THAT THE KNIFE WIRE BROKE WHILE USING THE SPHINCTEROTOME. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680355 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED, THE 3-LUMEN SPHINCTEROTOME V BROKE WHEN ELECTRICITY WAS APPLIED. IT DID NOT FALL OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE (ENDOSCOPIC SPHINCTEROTOMY). THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584243 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THAT THE LUMEN SPHINCTEROTOME'S KNIFE WIRE WAS BROKEN WHEN THE ELECTRICITY WAS APPLIED, BUT DID NOT FALL OFF. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380768 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE 2-LUMEN SPHINCTEROTOME HAD THREE KNIVES THAT WERE BROKEN IN A ROW WHEN ELECTRICITY WAS APPLIED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THAT WAS COMPLETED USING SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378965 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THE SPHINCTEROTOME HAD THREE KNIVES THAT WERE BROKEN IN A ROW WHEN ELECTRICITY WAS APPLIED, BUT NONE FELL OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THAT WAS COMPLETED USING SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375006 ↗
• MalfunctionFeb 5, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE BROKE WHILE BEING INSERTED INTO THE BODY. THE PROCEDURE WAS COMPLETED USING A SIMILAR PRODUCT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647890 ↗
• MalfunctionJan 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE SHEATH OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS DISLODGED AND DEFORMED. THE ISSUE OCCURRED WHEN THE PHYSICIAN ATTEMPTED TO CUT THE DUODENAL PAPILLA DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ISSUES WERE FOUND DURING PRE-USE INSPECTION. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586538 ↗
• MalfunctionJan 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE KNIFE WIRE COATING OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME WAS PEELED OFF. THE COATING DID NOT FALL OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC 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 18578533 ↗
• MalfunctionJan 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE INSULATING COATING PART OF THE SINGLE USE 3 LUMEN SPHINCTEROTOME WAS "FLUFFY." THE ISSUE OCCURRED WHEN THE PHYSICIAN TRIED TO PERFORM EST 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 18578357 ↗
• MalfunctionJan 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE KNIFE OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME DID NOT POINT TOWARDS 11 O'CLOCK. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE WIRE SHEATHING WAS TORN. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515986 ↗
• MalfunctionDec 14, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SPHINCTEROTOME¿S KNIFE WIRE BROKE. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC PAPILLARY SPHINCTEROTOMY PROCEDURE. THE DEVICE WAS EXCHANGED FOR A SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER REPORTED COMPLICATION. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325145 ↗
• MalfunctionDec 13, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE BROKE WHEN OUTPUTTING. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC PAPILLARY SPHINCTEROTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING SIMILAR EQUIPMENT. NO EFFECTS ON PATIENTS WERE INDICATED. THERE WERE NO REPORTS OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320081 ↗
• MalfunctionDec 12, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE 3- LUMEN SPHINCTEROTOME KNIFE WIRE BROKE WHEN OUTPUTTING. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC PAPILLARY SPHINCTEROTOMY. THE PROCEDURE WAS COMPLETED WITH SIMILAR EQUIPMENT. THE DEVICE WAS INSPECTED BEFORE USE AND WAS OKAY. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY. ADDITIONALLY, THIS HAS HAPPENED SEVERAL TIMES IN THE PAST, AND HAS BEEN REPORTED THAT WIRE BREAKS HAVE BEEN OCCURRING FREQUENTLY RECENTLY. TWO CASES OF SIMILAR DEFECTS HAVE OCCURRED, AND THREE CASES HAVE BEEN FILED INCLUDING THOSE THAT HAVE OCCURRED IN THE PAST. THIS CASE IS FOR CASES THAT HAVE OCCURRED IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314437 ↗
• MalfunctionOct 24, 2023Break; Break

  THE CUSTOMER REPORTED THAT WHILE PERFORMING AN ENDOSCOPIC SPHINCTEROTOMY PROCEDURE WITH HIS OLYMPUS SINGLE-USE 3-LUMEN SPHINCTEROTOME V, THE KNIFE BROKE DURING THE FIRST HIGH-FREQUENCY OUTPUT. ACCORDING TO THE INITIAL REPORTER, THERE WAS NO INTERNAL SHEDDING, AND THE SETTING VALUE WAS UNKNOWN. REPORTEDLY, THE PROCEDURE WAS COMPLETED BY REPLACING THE UNIT WITH ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994891 ↗
• MalfunctionSep 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE 3-LUMEN SPHINCTEROTOME V THE KNIFE WIRE BROKE AT THE SECOND ENERGIZATION. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760653 ↗
• MalfunctionJul 21, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE KNIFE WIRE OF  SINGLE USE 3-LUMEN SPHINCTEROTOME V WAS BROKEN WHEN ENERGIZED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. THE NEW SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. THE HIGH FREQUENCY SETTING VALUE AND OUTPUT MODE ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372458 ↗
• MalfunctionJul 7, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT, DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, THE KNIFE WIRE OF THEIR SINGLE USE 3-LUMEN SPHINCTEROTOME V DEVICE BROKE WHEN ENERGIZED. THE ELECTRIC KNIFE USED IN CONJUNCTION WITH THE PRODUCT WAS ESG-100, AND THE SETTING WAS PULSE-CUT, SLOW, 80W. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SIMILAR REPLACEMENT DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280170 ↗
• MalfunctionJun 19, 2023Break; Break

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST), THE KNIFE WIRE BROKE WHEN TWO KD-V411M-0725/KD-V411M-1530 WIRES WERE ENERGIZED. THE ORDER IN WHICH THE DEVICES WERE USED IS UNKNOWN. THE FIRST KNIFE WIRE BROKE AFTER MULTIPLE ENERGIZATIONS AND THE SECOND AND THIRD KNIFE WIRES BROKE DURING THE FIRST ENERGIZATION. THE PROCEDURE WAS COMPLETED BY REPLACING THE BALLOON WITH A DILATATION BALLOON. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6). RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159961 ↗
• MalfunctionJun 19, 2023Break; Break

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST), THE KNIFE WIRE BROKE WHEN TWO KD-V411M-0725/KD-V411M-1530 WIRES WERE ENERGIZED. THE ORDER IN WHICH THE DEVICES WERE USED IS UNKNOWN. THE FIRST KNIFE WIRE BROKE AFTER MULTIPLE ENERGIZATIONS AND THE SECOND AND THIRD KNIFE WIRES BROKE DURING THE FIRST ENERGIZATION. THE PROCEDURE WAS COMPLETED BY REPLACING THE BALLOON WITH A DILATATION BALLOON. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6). RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159945 ↗
• MalfunctionMay 23, 2023Break; Melted; Break; Melted

  ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. DUE TO A MISTRANSLATION OF THE EVENT DESCRIPTION. THE NURSE WAS NOT "ENERGIZED" OR INJURED; THE NURSE WAS JUST REPORTING THE EVENT, AND THE CUSTOMER WAS NOT SURE ABOUT WHETHER THE KNIFE WIRE WAS ENERGIZED WHEN THE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986647 ↗
• MalfunctionApr 28, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE KNIFE WIRE OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME V BROKE WHEN POWER WAS APPLIED DURING AN ENDOSCOPIC SPHINCTEROTOMY (DUODENAL PAPILLOTOMY) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833114 ↗