Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC611Q-07201S (REF N5778230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170399381), received between Jan 10, 2019 and Apr 21, 2026 — classified as 1 injury, 9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Material Fragmentation

  IT WAS REPORTED THE SINGLE-USE PRELOADED SPHINCTEROTOME'S ISOLATION [KNIFE WIRE] WAS HANGING LOOSE. THIS OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944584 ↗
• MalfunctionJul 31, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676340 ↗
• MalfunctionJun 27, 2025Break; Break

  NO NEW ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22351130 ↗
• MalfunctionDec 19, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE SPHINCTEROTOME CUTTING WIRE BROKE AT THE VERY END OF AN UNSPECIFIED THERAPEUTIC PROCEDURE WHICH WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT OR USER IMPACT OR ADDITIONAL OPERATING TIME DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359779 ↗
• MalfunctionApr 14, 2023Break; Material Frayed; Break; Material Frayed

  A COMPANY REPRESENTATIVE, ON BEHALF OF A USER FACILITY, REPORTED TO OLYMPUS THAT WHILE USING A SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED) DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, IT FRAYED/BROKE WHILE THE DEVICE WAS ENERGIZED. THERE WAS NO DEATH OR SERIOUS INJURY THAT OCCURRED, NOR INTERVENTION PERFORMED, BUT THERE WAS AN INCREASE IN PROCEDURE TIME WHICH WAS ONLY LONG ENOUGH TO OPEN AND INSERT A NEW DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT OUTCOME WAS STATED TO BE AS EXPECTED. THE USER FACILITY REPORTED THREE (3) INSTANCES OF FRAYING/BREAK. PATIENT IDENTIFIER (B)(6) IS FOR THE FIRST INSTANCE. PATIENT IDENTIFIER (B)(6) IS FOR THE SECOND INSTANCE. PATIENT IDENTIFIER (B)(6) IS FOR THE THIRD INSTANCE. THIS MDR IS FOR THE SECOND INSTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742901 ↗
• MalfunctionApr 14, 2023Break; Material Frayed; Break; Material Frayed

  A COMPANY REPRESENTATIVE, ON BEHALF OF A USER FACILITY, REPORTED TO OLYMPUS THAT WHILE USING A SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED) DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, IT FRAYED/BROKE WHILE THE DEVICE WAS ENERGIZED. THERE WAS NO DEATH OR SERIOUS INJURY THAT OCCURRED, NOR INTERVENTION PERFORMED, BUT THERE WAS AN INCREASE IN PROCEDURE TIME WHICH WAS ONLY LONG ENOUGH TO OPEN AND INSERT A NEW DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT OUTCOME WAS STATED TO BE AS EXPECTED. THE USER FACILITY REPORTED THREE (3) INSTANCES OF FRAYING/BREAK. PATIENT IDENTIFIER (B)(6) IS FOR THE FIRST INSTANCE. PATIENT IDENTIFIER (B)(6) IS FOR THE SECOND INSTANCE. PATIENT IDENTIFIER (B)(6) IS FOR THE THIRD INSTANCE. THIS MDR IS FOR THE THIRD INSTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742864 ↗
• MalfunctionApr 14, 2023Break; Material Frayed; Break; Material Frayed

  A COMPANY REPRESENTATIVE, ON BEHALF OF A USER FACILITY, REPORTED TO OLYMPUS THAT WHILE USING A SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED) DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, IT FRAYED/BROKE WHILE THE DEVICE WAS ENERGIZED. THERE WAS NO DEATH OR SERIOUS INJURY THAT OCCURRED, NOR INTERVENTION PERFORMED, BUT THERE WAS AN INCREASE IN PROCEDURE TIME WHICH WAS ONLY LONG ENOUGH TO OPEN AND INSERT A NEW DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT OUTCOME WAS STATED TO BE AS EXPECTED. THE USER FACILITY REPORTED THREE (3) INSTANCES OF FRAYING/BREAK. (B)(6). THIS MDR IS FOR THE FIRST INSTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742822 ↗
• MalfunctionMar 16, 2023Break; Break

  AS REPORTED, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WHEN THE DOCTOR DECIDED TO CUT THE AMPULLA (SPHINCTEROTOMY), THE CUTTING WIRE BROKE SUDDENLY WHEN DOCTOR PUSHED ON THE PADDLE OF THE ELECTROCAUTERY. THE DOCTOR WAS NOT ABLE TO CUT THE AMPULLA. NO INJURIES TO THE PATIENT. NOTHING LEFT IN THE PATIENT (WIRE), CONFIRM BY X-RAY. THE DOCTOR CHANGED THAT TOME AND TAKE ANOTHER ONE FROM BOSTON SCIENTIFIC (JAGTOME). THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THE PROCEDURE WAS EXTENDED WITH A MINIMAL TIME (UNSPECIFIC TIME), HOWEVER, NO IMPACT TO THE PATIENT, NO HARM WAS REPORTED, NO PATIENT INJURY, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16562236 ↗
• MalfunctionFeb 17, 2023Peeled/Delaminated; Material Separation; Material Split, Cut or Torn; Peeled/Delaminated; Material Separation; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE CUTTING WIRE ON THE SUBJECT DEVICE BROKE CLEANLY DURING A SPHINCTEROTOMY. A SECOND DEVICE WAS USED AND THE WIRE ON THAT DEVICE ALSO BROKE BUT THE PROCEDURE COULD BE COMPLETED. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. THE CUSTOMER NOTED THIS WAS A COMPLICATED PROCEDURE WITH A VERY LARGE STENOSIS OF THE BILE DUCT WITH DIFFICULTY IN TENSIONING THE WIRE. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE COATED PORTION OF THE CUTTING WIRE WAS TORN AND THE BROKEN PORTION WAS SCORCHED AND MELTED. THE COVERING OF THE WIRE WAS ALSO PEELED AND DISLODGED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (CUTTING WIRE TORN, SCORCHED, MELTED AND PEELED COVERING). THIS REPORT IS FOR THE FIRST DEVICE. THE SECOND DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400781 ↗
• InjuryJan 10, 2019Unclear Information; Unclear Information

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC PROCEDURE, THE DEVICE REPORTEDLY HAD AN UNSPECIFIED FAILURE AND CAUSED PATIENT INJURY.

  Patient problems: Injury

  MAUDE report 8234406 ↗