ELECTROSURGICAL KNIFE KD-31C-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170049323), received between Sep 15, 2022 and Jul 12, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TRANSBRONCHIAL NEEDLE ASPIRATION COMBINED WITH CRYOBIOPSY IN THE DIAGNOSIS OF MEDIASTINAL DISEASES: A MULTICENTRE, OPEN-LABEL, RANDOMISED TRIAL.¿ THIS PROSPECTIVE STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF COMBINED APPLICATION OF ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) AND MEDIASTINAL CRYOBIOPSY VERSUS EBUS-TBNA ALONE FOR THE DIAGNOSIS OF MEDIASTINAL DISEASES. A TOTAL OF 271 PATIENTS WERE RANDOMLY ASSIGNED TO RECEIVE EITHER EBUS-TBNA PLUS TRANSBRONCHIAL MEDIASTINAL CRYOBIOPSY (COMBINED GROUP; N=136) OR EBUS-TBNA ALONE (CONTROL GROUP; N=135; FIGURE). SEQUENTIAL APPLICATION OF EBUS-TBNA AND TRANS BRONCHIAL MEDIASTINAL CRYOBIOPSY LED TO A SIGNIFICANT INCREASE IN THE OVERALL DIAGNOSTIC YIELD COMPARED WITH EBUS-TBNA ALONE (126 [93%] OF 136 PARTICIPANTS IN THE COMBINED GROUP VS 109 [81%] OF 135 IN THE CONTROL GROUP. WHEREAS THE COMBINED BIOPSY WAS MORE SENSITIVE THAN EBUS-TBNA ALONE IN BENIGN DISEASES (45 [94%] OF 48 VS 28 [64%] OF 44, RR 1·47 [95% CI 1·17¿1·86]; P=0·0004. THE OVERALL DIAGNOSTIC YIELD OF 82% (110 OF 134 PARTICIPANTS) FOR EBUS-TBNA AND 91% (122 OF 134) FOR CRYOBIOPSY (RR 1·11 [9

  Patient problems: Dyspnea; Hemoptysis; Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 17304734 ↗
• 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 15429364 ↗
• 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 15428127 ↗