Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0320 (REF N5391030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170371073), received between May 31, 2022 and Sep 21, 2023 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) THE KNIFE WIRE WAS CUT AT THE TIMING OF ENERGIZATION. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC BILIARY ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17793934 ↗
• MalfunctionSep 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) WIRE KNIFE BROKE WHEN THE HIGH-FREQUENCY DEVICE WAS ENERGIZED. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC DUODENAL PAPILLOTOMY (EST). THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686689 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "LONG SLIMMER METAL STENT IS FEASIBLE AND EFFECTIVE FOR ENDOSCOPIC DUAL STENT-BY-STENT PLACEMENT IN MALIGNANT HILAR BILIARY STRICTURE". LITERATURE SUMMARY: THE AIM OF THIS STUDY WAS TO EVALUATE THE FEASIBILITY, EFFICACY, AND SAFETY OF THE NEW METAL STENT FOR PALLIATIVE TREATMENT OF MALIGNANT HILAR BILIARY STRICTURES (MHBS). THE TECHNICAL SUCCESS RATE WAS 100%, WITH A MEAN PROCEDURE TIME OF 43.7 ± 11.5 MIN. THE CLINICAL SUCCESS WAS ACHIEVED IN 44 PATIENTS (97.8%). EARLY ADVERSE EVENTS INCLUDED MILD ACUTE PANCREATITIS (N = 2) AND CHOLANGITIS (N = 3). LATER CHOLANGITIS OCCURRED IN 14 OF THE 45 PATIENTS DUE TO STENT OCCLUSIONS. THE MEDIAN STENT PATENCY WAS 260 DAYS (95% CI 228.3¿291.7). STENT MALFUNCTIONS OCCURRED IN 23 OF THE 45 PATIENTS, AND 15 OF THEM RECEIVED BILATERAL ENDOSCOPIC PLASTIC STENTS PLACEMENTS. THE TECHNICAL SUCCESS FOR THE RE-INTERVENTION WAS 100% WITH THE MEAN PROCEDURE TIME OF 24.3 ± 4.5 MIN. THE MEDIAN OVERALL SURVIVAL OF THE WHOLE GROUP WAS 229 DAYS (95% CI 171.2¿286.8). THE LONG SLIMMER METAL STENT FOR BILATERAL ENDOSCOPIC STENT-BY-STENT PLACEMENT PROVED TO BE SAFE, FEASIBLE, AND EFFECTIVE FOR MHBS AND FACILITATES E

  Patient problems: Pancreatitis; Unspecified Hepatic or Biliary Problem

  MAUDE report 14548309 ↗