Single Use 3-Lumen Sphincterotome V KD-V411M-0320 (UDI 04953170183973)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04953170183973), received between Oct 15, 2021 and Apr 29, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Break” (20 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 7, 2026Class IIOpen, Classified

   Devices which did not undergo thermoforming could deform and lose performance.

   Z-1268-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THE SINGLE USE 3-LUMEN SPHINCTEROTOME TIP OF THE CLEVER CUT WAS GETTING DAMAGED OR BROKEN IN A SINGLE USE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029154 ↗
• MalfunctionAug 27, 2025Break; Material Separation; Break; Material Separation

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907456 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V KNIFE WIRE BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC PAPILLOTOMY OF THE DUODENUM 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 20464568 ↗
• MalfunctionJul 17, 2024Material Separation; Material Separation

  DURING THE DEVICE EVALUATION, THE SPHINCTEROTOME'S COVER WAS PEELED AND THE KNIFE WIRE WAS EXPOSED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767354 ↗
• MalfunctionApr 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SPHINCTEROTOME VIDEOSCOPE EXHIBITED: DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, WHEN OPENING THE SPHINCTEROTOME AND TESTING IT, THE KNIFE WIRE WAS DAMAGED. THERE WAS NO ERROR MESSAGE. THE PROCEDURE WAS DELAYED FOR 18 MINUTES, AND THE PATIENT WAS ALREADY UNDER GENERAL ANESTHESIA. THE PRODUCT WAS REPLACED WITH ONE OF THE SAME MODEL AND LOT TO FINISH THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM, AND THE PATIENT WAS STABLE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133611 ↗
• MalfunctionApr 9, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE SPHINCTEROTOME CUTTING WIRE DID NOT RETURN TO ITS ORIGINAL POSITION. THE ISSUE OCCURRED DURING PREPARATION FOR USE IN A THERAPEUTIC ENDOSCOPIC CHOLANGIOGRAPHY PROCEDURE. THE PROCEDURE WAS DELAYED BY 18 MINUTES AND COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069687 ↗
• MalfunctionAug 28, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V CUTTING WIRE WAS BENT TO PERFORM THE PAPILLOTOMY, BUT WHEN CONNECTING THE SCALPEL WITH A CURRENT OF 40 WATTS THERE WAS A BREAKAGE OF THE CUTTING WIRE BROKE ON THE FIRST POWER ON. THE ISSUE WAS FOUND WHEN STARTING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH THE CATHETERIZATION OF THE PAPILLA WITH THE PAPILOTOM. 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 17638320 ↗
• MalfunctionAug 8, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE 3-LUMEN SPHINCTEROTOME V TIP KNIFE WIRE WAS BROKEN DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE NEW SIMILAR DEVICE WAS USED TO COMPLETE THE DIAGNOSTIC PROCEDURE. THE DEVICE HAD NO ABNORMALITIES DURING INSPECTION BEFORE USE. THERE ARE NO REPORTS THAT THE TIP OF THE KNIFE FELL INSIDE THE PATIENT NOR WERE THERE ANY REPORTS OF AN URGENT RETRIEVAL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484758 ↗
• MalfunctionAug 4, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC PAPILLARY SPHINCTEROTOMY, THE KNIFE WIRE BROKE. AT THE BEGINNING OF THE PROCEDURE, THE GUIDEWIRE COULD NOT BE PASSED THROUGH, AND A SIMPLE CUT WAS MADE WITHOUT THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466930 ↗
• MalfunctionJul 20, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING A SINGLE USE 3-LUMEN SPHINCTEROTOME V, THE KNIFE WIRE BROKE DURING THE THIRD ENERGIZATION. THE THERAPEUTIC PROCEDURE ( ENDOSCOPIC SPHINCTEROTOMY) WAS COMPLETED USING A SIMILAR DEVICE, AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368230 ↗
• MalfunctionMay 31, 2023Break; Break

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC PAPILLOTOMY THE KNIFE WIRE BROKE. THE EVENT OCCURRED AFTER THE FIRST TIME BEING INSERTED IN THE ENDOSCOPE. THE KNIFE WIRE DROPPED OUTSIDE OF THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035201 ↗
• MalfunctionJan 4, 2023Break; Break

  THERE WAS AN APPROXIMATE 10 MINUTE DELAY FOR DEVICE REPLACEMENT, AND IT IS UNKNOWN WHETHER PATIENT WAS UNDER ANESTHESIA AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16093724 ↗
• MalfunctionNov 1, 2022Break; Melted; Material Split, Cut or Torn; Break; Melted; Material Split, Cut or Torn

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE KNIFE WIRE BROKE WHEN CURRENT WAS APPLIED. THE PROCEDURE WAS COMPLETED BY REPLACING THE SUBJECT DEVICE WITH A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT OR USER INJURY ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15711962 ↗
• MalfunctionAug 22, 2022Break; Break

  CUSTOMER REPORTED THAT DURING PRE USE INSPECTION/ PREPARATION FOR USE AND WHEN OPERATED THE DEVICE WITH MODEL KD-V451M, IT WAS OBSERVED THAT THE KNIFE COULD NOT PROTRUDE. THE DEVICE WAS REPLACED WITH ANOTHER SIMILAR DEVICE AND THE INTENDED PROCEDURE WAS COMPLETED WITH NO PATIENT HARM OR INJURY REPORTED. THERE WAS NO USER INJURY REPORTED DUE TO THE EVENT. DEVICE RETURN EVALUATION FOUND THE KNIFE WIRE OF THE DEVICE MODEL KD-V411M-0320 (NOT THE MODEL KD-V451M CUSTOMER PREVIOUSLY REPORTED) WAS BROKEN AND THE BROKEN PART WAS FOUND CHARRED AND MELTED. THIS REPORT IS BEING SUBMITTED FOR BROKEN KNIFE WIRE FOUND ON DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271903 ↗
• MalfunctionAug 5, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC DUODENAL PAPILLOTOMY PROCEDURE, THE DOCTOR BROKE THE KNIFE [WIRE] OF THE SUBJECT DEVICE, AT THE END OF THE NIPPLE INCISION. THE DOCTOR COMPLETED THE PROCEDURE WITHOUT CHANGING THE EQUIPMENT. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, IN ADDITION TO THE BROKEN KNIFE WIRE, IT WAS OBSERVED THAT THE WIRE COVERING WAS TORN AND MISSING APPROXIMATELY 8.0-10.0 MM FROM THE TIP. THIS REPORT IS BEING SUBMITTED FOR BOTH MALFUNCTIONS, THE KNIFE WIRE BREAK, AND THE MISSING KNIFE WIRE COATING. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT, INCLUDING WHETHER THE KNIFE WIRE AND/OR THE MISSING COATING FELL INTO THE PATIENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15175268 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "A RARE BUT LETHAL COMPLICATION: POST-ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY CEREBRAL ARTERIAL GAS EMBOLISM" BY HIN SAN CHOW ET AL. IATROGENIC AIR EMBOLISM IS A RARE AND POTENTIALLY FATAL COMPLICATION OF GASTROINTESTINAL ENDOSCOPY. THE STUDY PRESENTED A 66-YEAR-OLD MALE PATIENT WHO DEVELOPED CEREBRAL ARTERIAL GAS EMBOLISM SHORTLY AFTER THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR ACUTE BILIARY PANCREATITIS, WHICH IS THE FIRST CASE REPORTED IN HONG KONG ACCORDING TO LATEST LITERATURE SEARCH. SOME RISK FACTORS OF IATROGENIC AIR EMBOLISM IN THIS PATIENT INCLUDE CHOLANGITIS WITH INTRADUCTAL STONES, SPHINCTEROTOMY AND BLEEDING AT PAPILLOTOMY SITE WHICH REQUIRED HAEMOSTASIS WITH BALLOON TAMPONADE. EARLY DIAGNOSIS AND TIMELY TREATMENT WITH HYPERBARIC OXYGEN THERAPY RESULTED IN FULL NEUROLOGICAL RECOVERY OF THE PATIENT. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS POST-ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY CEREBRAL ARTERIAL GAS EMBOLISM - (1)

  Patient problems: Embolism/Embolus

  MAUDE report 14192726 ↗
• MalfunctionApr 11, 2022Break; Break

  IT WAS REPORTED THAT DURING EST (ENDOSCOPIC SPHINCTEROTOMY) ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE, THE CUTTING WIRE BROKE INSIDE THE PATIENT AND WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14078501 ↗
• MalfunctionMar 19, 2022Break; Break

  THE DEVICE WAS RETURNED BY THE CUSTOMER FOR THE ISSUE OF THE KNIFE WIRE OF THE DEVICE BEING IN THE WRONG DIRECTION WHEN REMOVED FROM THE STERILE PACKAGING DURING PREPARATION FOR USE. THE DEVICE WAS NOT USED IN THE PROCEDURE AND THE INTENDED PROCEDURE WAS COMPLETED WITH A NEW DEVICE. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE KNIFE WIRE WAS BROKEN ON THE WIRE COATING. THE WIRE COATING WAS TORN AND THE BROKEN PART WAS SCORCHED AND MELTED, INDICATING THAT THE DEVICE WAS ACTIVATED. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE BROKEN KNIFE AND BROKEN PART BEING SCORCHED AND MELTED AS OBSERVED DURING DEVICE EVALUATION. ADDENDUM MAR 9, 2022: CUSTOMER PROVIDED ADDITIONAL INFORMATION THAT PRE-INSPECTION WAS NOT PERFORMED BEFORE INSERTING THE DEVICE TO THE ENDOSCOPE. THE BREAKAGE OF THE CUTTING WIRE WAS FOUND DURING AN ATTEMPT OF ACTIVATION. IT IS UNKNOWN WHETHER THE OUTPUT OF THE DEVICE WAS ACTIVATED ONCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13826868 ↗
• MalfunctionMar 16, 2022Break; Melted; Break; Melted

  IT WAS REPORTED THAT THE KNIFE BROKE DURING AN EST (ENDOSCOPIC SPHINCTEROTOMY) PROCEDURE. IT IS UNKNOWN WHETHER OR NOT IT INVOLVES ENERGIZATION. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE AND THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. DEVICE EVALUATION FOUND THE COATED PORTION OF THE CUTTING WIRE WAS TORN, AND THE BROKEN PORTION WAS SCORCHED AND MELTED. THIS REPORT IS BEING SUBMITTED FOR THE COATED PORTION OF THE CUTTING WIRE WAS TORN, AND THE BROKEN PORTION WAS SCORCHED AND MELTED (KNIFE WIRE BREAKAGE WHEN ENERGIZED) FOUND DURING DEVICE RETURN EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13781446 ↗
• MalfunctionFeb 18, 2022Break; Melted; Break; Melted

  THE CUSTOMER REPORTED THE KNIFE WIRE OF THE SPHINCTEROTOME BROKE DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WHEN THE HIGH FREQUENCY WAS OUTPUT. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE OF THE SAME MODEL. THERE WAS NO IMPACT ON THE PATIENT. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13561052 ↗
• MalfunctionFeb 7, 2022Break; Break

  THE CUSTOMER REPORTED THE KNIFE WIRE OF THE SPHINCTEROTOME BROKE DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476393 ↗
• MalfunctionDec 6, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) USING THE SUBJECT DEVICE, THE KNIFE WAS BROKEN OFF AT THE FIRST ACTIVATION. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS USED IN COMBINATION WITH ANOTHER COMPANY'S ELECTROSURGICAL UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12940335 ↗
• MalfunctionDec 6, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) USING THE SUBJECT DEVICE, THE KNIFE WAS BROKEN OFF AT THE FIRST ACTIVATION. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS USED IN COMBINATION WITH ANOTHER COMPANY'S ELECTROSURGICAL UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12940281 ↗
• MalfunctionOct 15, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY A NURSE THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY USING THE SUBJECT DEVICE WITH ESG-300 AND TJF-Q290V, THE CUTTING WIRE WAS BROKEN OFF ON ACTIVATION. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION AND INVESTIGATION. OMSC FOUND THAT NOT ONLY THE CUTTING WIRE WAS BROKEN BUT ALSO THE COATED PORTION OF THE CUTTING WIRE WAS TORN, AND THE BROKEN PORTION WAS SCORCHED AND MELTED. ALSO. THE LENGTH OF THE CUTTING WIRE AND THE COATED PORTION WAS MEASURED. THE DISTAL SIDE OF THE COATED PORTION WAS MISSING APPROXIMATELY 5.5-7.5 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638155 ↗