Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0720 (REF N5391230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170371110), received between Aug 27, 2021 and Feb 10, 2023 — classified as 7 injuries.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 7, 2026Class IIOpen, Classified

   Devices which did not undergo thermoforming could deform and lose performance.

   Z-1278-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE ADVERSE EVENTS, NOR MALFUNCTION DURING ANY OF THE PROCEDURES DESCRIBED IN THE ARTICLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16354841 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE ADVERSE EVENTS, NOR MALFUNCTION DURING ANY OF THE PROCEDURES DESCRIBED IN THE ARTICLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16344032 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "A NOVEL SELF-ASSEMBLING PEPTIDE HEMOSTATIC GEL AS AN OPTION FOR INITIAL HEMOSTASIS IN ENDOSCOPIC SPHINCTEROTOMY-RELATED HEMORRHAGE: A CASE SERIES". ENDOSCOPIC SPHINCTEROTOMY (EST) IS A FUNDAMENTAL PROCEDURE OF THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, WITH POST-EST BLEEDING AS A SERIOUS ADVERSE EVENT. ALTHOUGH THERE ARE VARIOUS HEMOSTATIC METHODS FOR POST-EST BLEEDING, THERE IS NO CONSENSUS REGARDING THE TREATMENT CHOICE. PURASTAT IS A NOVEL SELF-ASSEMBLING PEPTIDE DEVELOPED AS A HEMOSTATIC AGENT. WE REPORT SIX CASES OF EST-RELATED HEMORRHAGE WITH INITIAL HEMOSTASIS ACHIEVED USING PURASTAT. THE CASES WERE OBSERVED IN FOUR MEN AND TWO WOMEN, WITH AN AVERAGE AGE OF 77.8 YEARS. EST WAS PERFORMED FOR BILIARY DRAINAGE IN FOUR CASES AND FOR STONE REMOVAL IN TWO CASES. BLEEDING OCCURRED DURING THE SAME SESSION AS EST IN FVE OF SIX CASES, WITH THE REMAINING CASE SHOWING BLEEDING 4 DAYS AFTER EST. AS ALL PATIENTS WITH EST-RELATED HEMORRHAGE PRESENTED OOZING WITH STABLE VITAL SIGNS, WE SELECTED PURASTAT AS FRST-LINE HEMOSTASIS IN EACH CASE. WE APPLIED PURASTAT USING A DEDICATED CATHETER WITH THE TIP PRESSED AGAINST THE BLEE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16342778 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE ADVERSE EVENTS, NOR MALFUNCTION DURING ANY OF THE PROCEDURES DESCRIBED IN THE ARTICLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16342650 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE ADVERSE EVENTS, NOR MALFUNCTION DURING ANY OF THE PROCEDURES DESCRIBED IN THE ARTICLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16342542 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE ADVERSE EVENTS, NOR MALFUNCTION DURING ANY OF THE PROCEDURES DESCRIBED IN THE ARTICLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16342539 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED "PERCUTANEOUS TRANSHEPATIC PLACEMENT OF PLASTIC BILIARY STENTS: TECHNICAL DESCRIPTION AND PRELIMINARY RESULTS, " ONE PATIENT EXPERIENCED CHOLANGITIS (REQUIRING INTERVENTION). THIS WAS A PROSPECTIVE COHORT SINGLE-ARM SINGLE-CENTER PILOT STUDY AIMED TO EVALUATE THE FEASIBILITY AND SAFETY OF PERCUTANEOUS TRANSHEPATIC (PTH) PLACEMENT OF A PLASTIC BILIARY STENT (PBS) IN PATIENTS WITH BENIGN OR MALIGNANT SYMPTOMATIC OBSTRUCTIVE JAUNDICE (SOJ). THIRTY-TWO PATIENTS WITH SOJ WERE INCLUDED IN THE STUDY AND EVALUATED FOR TECHNICAL SUCCESS, CLINICAL SUCCESS AND ANY COMPLICATIONS AND WERE FOLLOWED-UP BETWEEN 30 AND 60 DAYS AFTER STENTING FOR THE PRESENCE OF STENT OCCLUSION. THE STUDY REVEALED A 100% AND 93.7% TECHNICAL AND CLINICAL SUCCESS, RESPECTIVELY WITH 2 OBSERVED COMPLICATIONS: TRANSIENT HAEMOBILIA (WHICH RESOLVED WITHOUT INTERVENTION) AND CHOLANGITIS REQUIRING ANTIBIOTIC THERAPY AND PROLONGED HOSPITALIZATION. HENCE THE STUDY CONCLUDED THE PLACEMENT OF PBS BY PTH ACCESS WAS SAFE, EFFECTIVE, AND FEASIBLE. THE AUTHORING PHYSICIAN CONFIRMED THESE ADVERSE EFFECTS OCCURRED AFTER THE PBS 3-MONTH FOLLOW-UP EXAM USING A CLEVERCUT 3V SPHINCTEROTOME A

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12377186 ↗