Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC611Q-07301S (REF N5778430)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04953170399404), received between May 17, 2021 and Mar 19, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME V EXHIBITED THE CUTTING WIRE BROKE ON THE SECOND PASS. THE ISSUE OCCURRED DURING A THERAPEUTIC GASTROINTESTINAL ENDOSCOPY /RETROGRADE CATHETERIZATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641158 ↗
• MalfunctionFeb 17, 2026Material Twisted/Bent; Inadequate Lubrication

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISTAL WIREGUIDE EXHIBITED AN UNCOATED AREA ON THE GUIDE WIRE, AND THE INSERTION PORTION WAS BUCKLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369631 ↗
• MalfunctionAug 27, 2025Material Frayed; Material Frayed

  DURING DEVICE EVALUATION, IT WAS OBSERVED THAT THE COATED PORTION OF THE CUTTING WIRE ON THE SINGLE-USE PRELOADED SPHINCTEROTOME WAS TORN AND PEELING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22902783 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT THE CUTTING WIRE ON THE SPHINCTEROTOME BROKE WHEN IT WAS TIGHTENED. THE EVENT OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ECRP). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149987 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE BROKE DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE AND THERE WERE NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035441 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THE SINGE USE PRELOADED SPHINCTEROTOME WIRE BROKE DURING A PROCEDURE. THE ISSUE OCCURRED AT AN UNKNOWN POINT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THERE WAS NO REPORT OF ANY DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 21922079 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME V GUIDEWIRE BROKE IN THE DISTAL PART OF THE SPHINCTEROTOME. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526761 ↗
• MalfunctionOct 21, 2024Break; Break

  IT WAS REPORTED THE SPHINCTEROTOME V HAD DAMAGE TO THE KNIFE WIRE. THE ISSUE OCCURRED DURING A SPHINCTEROTOMY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF ANY DELAYS, INJURY, OR DEATH. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496956 ↗
• MalfunctionSep 6, 2024Sparking; Sparking

  IT WAS REPORTED, THE SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED) WAS DAMAGED AND SPARKED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE AND THERE WAS A 5 MINUTE DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156119 ↗
• MalfunctionSep 5, 2024Thermal Decomposition of Device; Material Split, Cut or Torn; Thermal Decomposition of Device; Material Split, Cut or Torn

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COATED PORTION OF THE CUTTING WIRE OF PRELOADED SPHINCTEROTOME WAS TORN, AND THE BROKEN PORTION WAS SCORCHED AND MELTED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148314 ↗
• MalfunctionAug 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THAT THE SINGLE USE PRELOADED SPHINCTEROTOME. THE CUTTING WIRE DISENGAGED. THE ISSUE OCCURRED, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). FOR STENOTIC TUMORAL GALLSTONES. THE INTENDED PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19969434 ↗
• MalfunctionAug 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SINGLE USE PRELOADED SPHINCTEROTOME, THE CUTTING WIRE DISENGAGED. THE ISSUE OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR STENOTIC TUMORAL GALLSTONES. THE INTENDED PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967144 ↗
• MalfunctionJul 9, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE SINGLE USE PRELOADED SPHINCTEROTOME'S KNIFE WIRE COVERING WAS PEELED AND DISLODGED. THE ISSUE OCCURRED DURING AN ENDOSCOPIC PAPILLOTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706909 ↗
• InjuryMar 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A USER FACILITY REPORTED THAT WHILE USING A SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED) DURING A PAPILLOTOMY, AFTER 3 DELIVERIES OF CURRENT AND CUTS, THE CUTTING WIRE BROKE/TORE OFF THE PAPILLOTOME. THE PATIENT EXPERIENCED A PERFORATION AND BLED. IT WAS STATED THAT THERE WAS POSSIBLE SCARRING, WITH A CONCERN REGARDING ADHESIONS AT A LATER DATE. NOTHING REMAINED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING INTERVENTIONS AND THE OUTCOME MULTIPLE TIMES, BUT HAS NOT BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16539630 ↗
• MalfunctionFeb 13, 2023Break; Break

  THE CUSTOMER REPORTED THAT, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE CUTTING WIRE OF THE SUBJECT DEVICE BROKE AT THE MIDPOINT BETWEEN THE CUTTING WIRE AND CLEVERCUT COATING. THE BREAKAGE OCCURRED DURING USE OF DIATHERMY AND THE SETTING USED WITH ESG-100 WAS PULSECUT SLOW 120. THE USER WAS ABLE TO CREATE A LITTLE SPHINCTEROTOMY BUT NOTICED ON RETRACTION THAT THE WIRE HAD SNAPPED OFF. THE PHYSICIAN ALSO STATED THE PATIENT HAS A FLAT PANCREATIC CUT AND THE DIFFICULTY IN CANNULATION WAS DUE TO THAT AND HAD TO USE THE DOUBLE GUIDEWIRE TECHNIQUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE AND THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362934 ↗
• MalfunctionJun 17, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER WAS ABOUT TO COMMENCE WITH THE ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) THERAPEUTIC PROCEDURE , DURING INSERTION, CUSTOMER HAS NOTICED THAT THE SHARP BURST OF INSERTION MAY HAVE KINKED THE TIP OF SPHINCTEROTOME. WHEN APPROACHING THE MUCOSA, THEY HAVE NOTICED THAT THERE WAS "SOMETHING STICKING OUT" AND THOUGHT IT WAS THE GUIDEWIRE. THE GUIDEWIRE WAS PULLED OUT AND INSPECTED BUT THERE WAS NO FAULT. THE SPHINCTEROTOME WAS THEN PULLED OUT AND INSPECTED AND SAW THAT THE CUTTING WIRE HAS BEEN BROKEN . THE CUSTOMER BELIEVES THAT IT WAS DUE TO THE SHARP INSERTION OF THE ITEM THROUGH THE BIOPSY CHANNEL. THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED USING SIMILAR DEVICE (BRAND NEW SPHINCTEROTOME WITH THE SAME SPECIFICATION). THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14738995 ↗
• MalfunctionJun 13, 2022Break; Break

  AS REPORTED "DURING THE PROCEDURE THE CUTTING WIRE OF THE SPHINCTEROTOME BROKE." NO PATIENT INJURY REPORTED. THERE WAS NO PATIENT HARM , NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14682231 ↗
• MalfunctionMar 24, 2022Break; Break

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC SPHINCTEROTOMY PROCEDURE, THE CUTTING WIRE OF THE SUBJECT DEVICE BROKE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13880218 ↗
• MalfunctionMar 17, 2022Break; Break

  THE CUSTOMER REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME V KNIFE BROKE DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13794985 ↗
• MalfunctionMar 12, 2022Break; Melted; Material Split, Cut or Torn; Break; Melted; Material Split, Cut or Torn

  THE PHARMACIST AT THE USER FACILITY REPORTED THAT THE CUTTING WIRE OF THE SPHINCTEROTOME BROKE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13742788 ↗
• MalfunctionMay 17, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) USING THE SUBJECT DEVICE, THE CUTTING WIRE WAS BROKEN. THERE WERE NO MISSING PARTS. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838944 ↗