Single Use 3-Lumen Needle Knife V KD-V451M (UDI 04953170244148)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170244148), received between Mar 28, 2022 and Sep 22, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Peeled/Delaminated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854562 ↗
• MalfunctionMar 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE COATED PORTION OF THE CUTTING KNIFE WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660098 ↗
• MalfunctionJan 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE KNIFE OF THE SINGLE USE 3-LUMEN NEEDLE KNIFE PIERCED THE SHEATH AND PROTRUDED. THE ISSUE OCCURRED WHEN THE DEVICE WAS INSERTED INTO A SCOPE AND THE PHYSICIAN TRIED TO PROJECT THE INCISION KNIFE AT THE TIP. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE WIRE SHEATHING HAD TURNED OVER TOWARD THE PROXIMAL SIDE. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569545 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: "CLINICOPATHOLOGICAL CHARACTERISTICS OF PATIENTS WITH PAIN AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTRIC EPITHELIAL NEOPLASM" BY JUNG-WOOK KIM ET AL.     LITERATURE SUMMARY: THIS RETROSPECTIVE STUDY WAS AIMED TO EXPLORE, BOTH THE INCIDENCE OF EPIGASTRIC PAIN AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND CLINICOPATHOLOGIC FACTORS ASSOCIATED WITH THE PAIN IN A LARGE NUMBER OF PATIENTS. THE STUDY RETROSPECTIVELY ANALYZED A PROSPECTIVELY COLLECTED REGISTRY OF CLINICAL, ENDOSCOPIC, AND PATHOLOGIC RESULTS OF 1266 PATIENTS WHO UNDERWENT ESD FOR GASTRIC ADENOMA OR CANCER. THE DATA WAS ANALYZED INCLUDED AGE, SEX, PATHOLOGY, SPECIMEN AND TUMOR SIZE, PROCEDURE TIME, AND TUMOR LOCATION. A VISUAL ANALOGUE SCALE (VAS) WAS USED TO ASSESS PAIN IMMEDIATELY AFTER, AND 2, 12, AND 24 H AFTER ESD WHILE THE PRIMARY OUTCOME WAS THE USE OF PAINKILLERS (VAS SCORE > 4). OF 1226 PATIENTS, 461 (36.4%) NEEDED A PAINKILLER AT LEAST ONCE AFTER ESD, WERE CONSIDERED AS THE PAIN GROUP. THE STUDY CONCLUDED THAT THE FACTORS INFLICTING PAIN AFTER ESD WERE INCLUDED FEMALE SEX, PROCEDURE TIME, AND LESION LOCATION. ALSO SUGGESTED THAT THE ENDOSCOPISTS SHOU

  Patient problems: Abdominal Pain; Fever; Hemorrhage/Blood Loss/Bleeding; Pneumonia

  MAUDE report 13929560 ↗