Single Use 3-Lumen Needle Knife V KD-V451M (UDI 04953170382710)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170382710), received between Aug 21, 2018 and Oct 3, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "VISIBILITY OF THE BILIARY ORIFICE AFTER PRECUT PAPILLOTOMY: COMPARISON BETWEEN WHITE LIGHT IMAGING AND TEXTURE AND COLOR ENHANCEMENT IMAGING." LITERATURE SUMMARY BACKGROUND: PRECUT PAPILLOTOMY IS PERFORMED IN CASES OF DIFFICULT BILIARY CANNULATION, BUT IDENTIFICATION OF THE BILIARY ORIFICE IS DIFFICULT. TEXTURE AND COLOR ENHANCEMENT IMAGING (TXI) CAN ENHANCE THE STRUCTURE, COLOR, AND BRIGHTNESS. THIS STUDY COMPARED TXI AND WHITE LIGHT IMAGING (WLI) IN VISIBILITY OF BILIARY ORIFICES. METHODS: WE RETROSPECTIVELY EXAMINED 20 PATIENTS WHO UNDERWENT BILE DUCT CANNULATION USING BOTH WLI AND TXI AFTER PRECUT PAPILLOTOMY AT OUR CENTER BETWEEN 2021 AND 2022. ON WLI AND TXI IMAGES DISPLAYED IN RANDOM ORDER, BILE DUCT ORIFICE ON PRECUT-INCISION SURFACE OF EACH IMAGE WAS INDEPENDENTLY EVALUATED BY EIGHT EVALUATORS. SINGLE-INDICATION ACCURACY RATE OF BILIARY ORIFICES, VISIBILITY SCORE RATED ON A 4-GRADE SCALE, AND COLOR DIFFERENCE BETWEEN THE BILIARY ORIFICE AND THE SURROUNDING TISSUE WERE EXAMINED. RESULTS: THE SINGLE-INDICATION ACCURACY RATE WAS HIGHER IN TXI COMPARED TO WLI ((B)(4), ODDS RATIO 2.26 [(B)(4) CI: 1.32¿3.89], P = (B)(4)). THE TI

  Patient problems: Pancreatitis

  MAUDE report 20364328 ↗
• MalfunctionJan 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE SINGLE USE 3-LUMEN NEEDLE KNIFE PROTRUDED FROM THE SIDE OF THE SHEATH AND NOT THE TIP. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE AND WAS CONFIRMED ON THE ENDOSCOPE SCREEN. 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 18593904 ↗
• MalfunctionJan 10, 2024Break; Break

  THE CUSTOMER REPORTED THE KNIFE WIRE OF THE SINGLE USE 3-LUMEN NEEDLE KNIFE V WAS BROKEN AND NO OUTPUT WAS PRODUCED. THE ISSUE OCCURRED WHEN THE DEVICE WAS ENERGIZED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE HIGH FREQUENCY MODES USED WERE INCISION END CUT 1. 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 18481979 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS LITERATURE ARTICLE REQUIRES 3 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: 1. (B)(6). 2. (B)(6). 3. (B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Unspecified Hepatic or Biliary Problem

  MAUDE report 16640695 ↗
• InjurySep 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE KNIFE "DROPPED OUT" WHILE PHYSICIAN WAS CUTTING THE AMPULLA. CONSEQUENTLY, THE KNIFE BECAME STUCK IN THE MUCOSA, AND THE PHYSICIAN WAS ABLE TO RETRIEVE THE SUSPECT DEVICE USING FORCEPS. THERE WAS A PROCEDURAL DELAY OF APPROXIMATELY 10 MINUTES, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15350353 ↗
• MalfunctionAug 21, 2018Break; Break

  DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST), THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, TIP OF THE NEEDLE KNIFE OF THE DEVICE BROKEN OFF AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE NEEDLE KNIFE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7803965 ↗