Single Use 3-Lumen Sphincterotome V KD-V411M-0330 (UDI 04953170382611)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170382611), received between Oct 13, 2020 and Jul 21, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE KNIFE WIRE OF THE SINGLE USE 3-LUMEN SPHINCTEROTOME V NORMALLY FACES THE 11 O¿CLOCK DIRECTION, BUT IT WOULD ONLY FACE THE 1 O¿CLOCK TO 4 O¿CLOCK DIRECTIONS. THE ISSUE WAS FOUND DURING THE PROCEDURE. THE SAME PROBLEM OCCURRED WITH THE SECOND REPLACEMENT. WHEN THE PERSON IN CHARGE OF THE FACILITY CHECKED THE DEVICES, ONE OF THEM HAD A BROKEN KNIFE WIRE. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH A THIRD DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372097 ↗
• MalfunctionJun 28, 2023Melted; Material Separation; Melted; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING A SINGLE USE 3-LUMEN SPHINCTEROTOME V, THE KNIFE WIRE WAS BROKEN. THE USER SWITCHED TO A SECOND SIMILAR DEVICE, AND THAT KNIFE WIRE DID NOT FACE THE 11 O¿CLOCK DIRECTION. THE USER COMPLETED THE THERAPEUTIC PROCEDURE (ENDOSCOPIC SPHINCTEROTOMY) WITH A THIRD SIMILAR PRODUCT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217800 ↗
• MalfunctionMay 9, 2022Break; Break

  OLYMPUS WAS INFORMED THAT THE KNIFE WIRE OF THE CUSTOMER SINGLE-USE 3- LUMEN SPHINCTEROTOME V ¿BROKE WHEN ENERGIZED¿ DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE DEVICE WAS REPLACED WITH A NEW ONE AND THE INTENDED PROCEDURE WAS COMPLETED. THERE IS NO PATIENT HEALTH HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14343074 ↗
• MalfunctionApr 8, 2022Break; Break

  THE CUSTOMER REPORTED THAT WHILE PREPARING THE SUBJECT DEVICE FOR AN UNSPECIFIED PROCEDURE, THE KNIFE WIRE BROKE BUT IT WAS NOT ENERGIZED AND HAD NOT FALLEN OFF. ANOTHER DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE INTENDED PROCEDURE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE BROKEN PART OF THE KNIFE WIRE WAS BURNT AND IT APPEARED THAT IT HAD BEEN BROKEN BY ENERGIZATION. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (THE KNIFE WIRE WAS BURNT AND BROKEN BY ENERGIZATION). ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14063079 ↗
• MalfunctionApr 5, 2022Break; Melted; Break; Melted

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, THE KNIFE WIRE BROKE WHEN IT WAS ENERGIZED. ANOTHER DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE INTENDED PROCEDURE. THERE WAS NO PROLONGATION OF THE PROCEDURE. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018216 ↗
• MalfunctionSep 27, 2021Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SPHINCTEROTOMY PROCEDURE, THE BLADE OF THE DEVICE BROKE NEAR THE PROXIMAL PART. THE BROKEN PIECE WAS RETRIEVED. THERE WAS A DELAY OF FIVE MINUTES IN THE PROCEDURE. THE DELAY WAS NOT CLINICALLY RELEVANT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531966 ↗
• MalfunctionOct 13, 2020Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST), THE SUBJECT DEVICE WAS USED. THE CUTTING WIRE OF THE SUBJECT DEVICE WAS TORN OFF DURING THE CUTTING OR DILATION OF THE PAPILLA. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10668372 ↗