Single Use 3-Lumen Needle Knife V KD-V441M (UDI 04953170382703)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170382703), received between May 28, 2019 and Jan 28, 2026 — 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.

• MalfunctionJan 28, 2026Activation Failure

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE-USE NEEDLE-KNIFE'S CUTTING WIRE WAS NOTED AS BROKEN/ SCORCHED AND MELTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24200042 ↗
• InjuryJan 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE 3-LUMEN NEEDLE KNIFE V WAS STUCK IN THE EVIS LUCERA DUODENOVIDEOSCOPE CHANNEL AND CAME OFF DURING AN UNKNOWN PROCEDURE. NEEDLE KNIFE DROPPED INSIDE THE PATIENT¿S BODY. NOTHING WAS LEFT INSIDE THE PATIENT AS THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. NO CLINICAL IMPACT AND PROCEDURE COMPLETED WITH THE SAME SCOPE. NO DELAY WAS REPORTED. NO PATIENT HARM WAS REPORTED. THE FOLLOWING 2 PATIENT IDENTIFIERS FOR BELOW 2 OLYMPUS DEVICES THAT WERE INVOLVED DURING A SINGLE EVENT. 1) PATIENT IDENTIFIER # (B)(6), SINGLE USE 3-LUMEN NEEDLE KNIFE V, MODEL: KD-V441M; SERIAL NUMBER- UNKNOWN (THIS REPORT). 2) PATIENT IDENTIFIER # (B)(6), EVIS LUCERA DUODENOVIDEOSCOPE, MODEL TJF-260V; SERIAL NUMBER- (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466547 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "CIRCUMFERENTIAL SUBMUCOSAL INCISION PRIOR TO ENDOSCOPIC MUCOSAL RESECTION VERSUS CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION FOR COLORECTAL LESIONS WITH ENDOSCOPIC FEATURES OF SESSILE SERRATED LESIONS". BACKGROUND: SESSILE SERRATED LESIONS (SSLS) ARE MORE PRONE TO INCOMPLETE RESECTION THAN CONVENTIONAL ADENOMAS. THIS STUDY EVALUATED WHETHER CIRCUMFERENTIAL SUBMUCOSAL INCISION PRIOR TO ENDOSCOPIC MUCOSAL RESECTION (CSI-EMR) CAN INCREASE THE RATE OF COMPLETE AND EN BLOC RESECTIONS OF COLORECTAL LESIONS WITH ENDOSCOPIC FEATURES OF SSL. METHODS RETROSPECTIVE ANALYSES AND PROPENSITY SCORE MATCHING WERE PERFORMED FOR THE RESECTION OF COLORECTAL LESIONS=10 MM WITH ENDOSCOPIC FEATURES OF SSL. RESULTS AFTER 1:1 RATIO MATCHING, 127 LESIONS IN THE CSI-EMR GROUP AND 127 IN THE EMR GROUP WERE SELECTED FOR ANALYSIS. THE MEDIAN SIZE OF THE LESIONS WAS 15 MM (IQR 12¿16) IN BOTH GROUPS. THERE WAS NO SIGNIFCANT DIFERENCE IN EITHER THE COMPLETE RESECTION RATE OR EN BLOC RESECTION RATE BETWEEN CSI-EMR AND EMR GROUPS (96.9% VS. 92.9%, P=0.155; 92.1% VS. 89.0%, P=0.391). BY CONTRAST, THE R0 RESECTION RATE WAS SIGNIFCANTLY HIGHER IN THE CSI-EMR GROUP THAN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16865634 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE ASSESSMENT OF THE ASGE-GRADING SYSTEM OF ERCP: A LARGE-SAMPLE RETROSPECTIVE STUDY." THIS RETROSPECTIVE STUDY AIMED TO ASSESS THE ASSOCIATION BETWEEN THE DEGREE OF DIFFICULTY FOR ERCP AND THE RATES OF SUCCESS AND ADVERSE EVENT, IN TURN DEMONSTRATING THE VALIDITY AND PRACTICALITY OF THIS SYSTEM. A TOTAL OF 20,652 ERCP PROCEDURES PERFORMED DURING THE STUDY PERIOD WERE ANALYZED. THE OVERALL SUCCESS RATE INCREASED FROM 92.8% TO 94.0%, WHILE THE DISTRIBUTION OF PROCEDURES AND THE INCIDENCE OF COMPLICATIONS SHOWED LITTLE VARIATION. THE SUCCESS RATE REVEALED A SIGNIFICANTLY DECREASING TREND WITH INCREASING DIFFICULTY (RANGING FROM 55.6 TO 98.6%), MAINLY FOR BILIARY DISEASES. IN ADDITION, THE DIFFICULTY SCALE WAS NOT ASSOCIATED WITH ANY DIFFERENCES IN THE RATE OF ADVERSE EVENT, EXCEPT FOR THE PANCREATITIS FOR GRADE 1 PROCEDURES, WHICH HAD A LOW INCIDENCE. THIS STUDY CONCLUDED THAT THE ASGE-GRADING SYSTEM CAN HELP PREDICT THE SUCCESS RATE OF ERCP PROCEDURES BUT SHOWED POOR PERFORMANCE IN PREDICTING ADVERSE EVENTS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: COHORT - 1. PANCREATITIS - 511 PATIENTS. BLEEDING - 410 PATIENTS. CHOLANGITIS - 62

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

  MAUDE report 15770768 ↗
• MalfunctionDec 30, 2021Break; Break

  THE CUSTOMER REPORTED THE TIP OF THE KD BROKE OFF AND WAS STUCK IN THE PAPILLA. THE INTENDED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE WAS SUCCESSFULLY COMPLETED USING A TJF ENDOSCOPE. THERE WAS AN UNSPECIFIED PROCEDURE DELAY DUE TO REMOVING THE BROKEN SEGMENT FROM THE PAPILLA. NO PATIENT HARM OR INJURY REPORTED. THE ERBE HF DEVICE WAS NORMAL KD SETTINGS. NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE WAS RETURNED FOR REPAIR. THE OLYMPUS SERVICE CENTER IDENTIFIED THE WIRE WAS BROKEN WITH ENERGIZATION. THIS IS A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122382 ↗
• MalfunctionMay 28, 2019Break; Break

  WE RECEIVED THE FOLLOWING REPORT. WHEN THE DOCTOR TRIED TO CUT THE PAPILLA, DISTAL END OF THE METAL WIRE OF THE SUBJECT DEVICE WAS BROKEN OFF DURING OPERATION. THE WIRE WAS LEFT AT THE PAPILLA (IT WAS PARTIALLY OUT OF THE PAPILLA). IT WAS LATER TAKEN OUT BY GRASPING FORCEPS. NO PATIENT INJURY REPORT WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8644791 ↗