UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER EU-ME1 (UDI 04953170263255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170263255), received between Sep 15, 2022 and Sep 15, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "IMPROVED DIAGNOSTIC YIELD AND SPECIMEN QUALITY WITH ENDOBRONCHIAL ULTRASOUND-GUIDED FORCEPS BIOPSIES: A RETROSPECTIVE ANALYSIS." BACKGROUND. ENDOBRONCHIAL ULTRASOUND (EBUS) TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) HAS A HIGH DIAGNOSTIC YIELD WHEN EVALUATING MEDIASTINAL AND HILAR LYMPHADENOPATHY (LAD). HAVING PREVIOUSLY DEMONSTRATED THE SAFETY OF EBUS-GUIDED CAUTERY-ASSISTED TRANSBRONCHIAL NODAL FORCEPS BIOPSY (CA-TBFB), WE REPORT DISEASE-SPECIFIC IMPROVEMENTS IN DIAGNOSTIC YIELD AND TISSUE ACQUISITION WHEN SUPPLEMENTING THE EBUS-TBNA¿BASED STANDARD OF CARE (SOC)WITH CA-TBFB. METHODS. WE RETROSPECTIVELY REVIEWED 213 PATIENTS WHO SEQUENTIALLY UNDERWENT SOC AND CA-TBFB DURING THE SAME PROCEDURE. WE DETERMINED 3 CLINICAL SCENARIOS OF INTEREST BASED ON PREPROCEDURAL IMAGING: ISOLATED MEDIASTINAL/HILAR LAD, LAD ASSOCIATED WITH A NODULE OR MASS SUSPICIOUS FOR MALIGNANCY, AND LAD ASSOCIATED WITH PARENCHYMAL FINDINGS SUGGESTIVE OF SARCOIDOSIS. USING VALIDATED METHODS, WE ASSESSED DIAGNOSTIC YIELD ON A PER-PATIENT BASIS AND SPECIMEN QUALITY ON A PER-NODE BASIS ON THE 136 PATIENTS MEETING DIAGNOSTIC CRITERIA. RESULTS. ADMINISTRATION OF DISEASE-

  Patient problems: Hemoptysis; Pneumonia; Pneumothorax; Respiratory Failure

  MAUDE report 15429443 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "IMPROVED DIAGNOSTIC YIELD AND SPECIMEN QUALITY WITH ENDOBRONCHIAL ULTRASOUND-GUIDED FORCEPS BIOPSIES: A RETROSPECTIVE ANALYSIS." BACKGROUND. ENDOBRONCHIAL ULTRASOUND (EBUS) TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) HAS A HIGH DIAGNOSTIC YIELD WHEN EVALUATING MEDIASTINAL AND HILAR LYMPHADENOPATHY (LAD). HAVING PREVIOUSLY DEMONSTRATED THE SAFETY OF EBUS-GUIDED CAUTERY-ASSISTED TRANSBRONCHIAL NODAL FORCEPS BIOPSY (CA-TBFB), WE REPORT DISEASE-SPECIFIC IMPROVEMENTS IN DIAGNOSTIC YIELD AND TISSUE ACQUISITION WHEN SUPPLEMENTING THE EBUS-TBNA¿BASED STANDARD OF CARE (SOC)WITH CA-TBFB. METHODS. WE RETROSPECTIVELY REVIEWED 213 PATIENTS WHO SEQUENTIALLY UNDERWENT SOC AND CA-TBFB DURING THE SAME PROCEDURE. WE DETERMINED 3 CLINICAL SCENARIOS OF INTEREST BASED ON PREPROCEDURAL IMAGING: ISOLATED MEDIASTINAL/HILAR LAD, LAD ASSOCIATED WITH A NODULE OR MASS SUSPICIOUS FOR MALIGNANCY, AND LAD ASSOCIATED WITH PARENCHYMAL FINDINGS SUGGESTIVE OF SARCOIDOSIS. USING VALIDATED METHODS, WE ASSESSED DIAGNOSTIC YIELD ON A PER-PATIENT BASIS AND SPECIMEN QUALITY ON A PER-NODE BASIS ON THE 136 PATIENTS MEETING DIAGNOSTIC CRITERIA. RESULTS. ADMINISTRATION OF DISEASE-

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemoptysis; Pneumonia; Pneumothorax; Respiratory Failure

  MAUDE report 15428043 ↗