Single Use 3-Lumen Needle Knife V KD-V441M (UDI 04953170244124)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170244124), received between Oct 6, 2021 and Nov 16, 2022 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY ANALYSIS OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR THE EARLY GASTRIC CANCER AND PRECANCEROUS LESIONS." ENDOSCOPIC TREATMENT OF PRECANCEROUS LESIONS AND EARLY GASTRIC CANCER HAS BEEN WIDELY ACCEPTED IN RECENT YEARS. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), FOLLOWING ESTABLISHED INDICATION CRITERIA, CAN LEAD TO CURE OF THE DISEASE IN MORE THAN 90% OF CASES. OBJECTIVE ¿ THIS STUDY AIMED TO ANALYZE THE USE OF ESD IN PATIENTS WITH EARLY GASTRIC CANCER AND PRECANCEROUS LESIONS, AS WELL AS THE RESULTS OF THE PROCEDURE, ITS COMPLICATIONS AND EFFECTIVENESS IN CONTROLLING THE DISEASE. METHODS ¿ THIS IS A RETROSPECTIVE COHORT STUDY COMPOSED OF 41 PATIENTS AGED FROM 53 TO 87 YEARS (MEAN AGE: 65 YEARS; 58.53% MALE) WHO WERE ANALYZED FROM 2008 TO 2019. THE VARIABLES COLLECTED FROM THE MEDICAL RECORDS WERE: COMORBIDITIES, CLASSIFICATION OF THE LESION REGARDING RESECTION CRITERIA, TYPE OF RESECTION, HISTOLOGY, DEGREE OF INVASION, RESECTION MARGIN, COMPLICATIONS, DISEASE RECURRENCE. STATISTICAL ANALYSIS WAS PERFORMED USING THE KRUSKAL-WALLIS TEST, THE MCNEMAR¿S TEST, AND THE MANN-WHITNEY TEST, WITH 5% STATISTICAL SIGNIFICANCE (P<0.05). RESULTS

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15807345 ↗
• MalfunctionNov 21, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE CUTTING WIRE BROKE WHEN ENERGIZED DURING A ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE BROKEN PARTS HAVE BEEN RECOVERED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849967 ↗
• MalfunctionOct 6, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE CUTTING KNIFE BROKE AND FELL OFF DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE USER FACILITY STATES THAT THE NON-OLYMPUS GENERATOR VIO300 SETTING WAS THE SAME AS USUAL AND NOT CHANGED. THE USER FACILITY RECOVERED THE DROPPED PART DURING THE PROCEDURE, THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12581903 ↗