Single Use Biopsy Forceps FB-433DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170394539), received between Sep 12, 2022 and Nov 18, 2024 — classified as 1 death, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ULTRATHIN BRONCHOSCOPY WITHOUT VIRTUAL NAVIGATION FOR DIAGNOSIS OF PERIPHERAL LUNG LESIONS". LITERATURE SUMMARY: BACKGROUND: THE INCREASING INCIDENCE OF ENCOUNTERING LUNG NODULES NECESSITATES AN ONGOING SEARCH FOR IMPROVED DIAGNOSTIC PROCEDURES. VARIOUS BRONCHOSCOPIC TECHNOLOGIES HAVE BEEN INTRODUCED OR ARE IN DEVELOPMENT, BUT FURTHER STUDIES ARE NEEDED TO DEFINE A METHOD THAT FITS BEST IN CLINICAL PRACTICE AND HEALTH CARE SYSTEMS. RESEARCH QUESTION HOW DO BASIC BRONCHOSCOPIC TOOLS INCLUDING A COMBINATION OF THIN (OUTER DIAMETER 4.2 MM) AND ULTRATHIN BRONCHOSCOPES (OUTER DIAMETER 3.0 MM), RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) AND FLUOROSCOPY PERFORM IN PERIPHERAL PULMONARY LESION DIAGNOSIS? STUDY DESIGN AND METHODS: THIS IS A RETROSPECTIVE REVIEW OF THE PERFORMANCE OF PERIPHERAL BRONCHOSCOPY USING THIN AND ULTRATHIN BRONCHOSCOPY WITH REBUS AND 2D FLUOROSCOPY WITHOUT A NAVIGATIONAL SYSTEM FOR EVALUATING PERIPHERAL LUNG LESIONS IN A SINGLE ACADEMIC MEDICAL CENTER FROM 11/2015 TO 1/2021. WE USED A STRICT DEFINITION FOR DIAGNOSTIC YIELD AND ASSESSED THE IMPACT OF DIFFERENT VARIABLES ON DIAGNOSTIC YIELD, SPECIFICALLY A

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 20705731 ↗
• InjuryNov 18, 2024Adverse 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 THE ADVERSE EVENT DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THE AUTHOR NOTED THAT ULTRATHIN SCOPE INCREASED THE DIAGNOSTIC YIELD IN ADDITION TO THE THIN SCOPE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 20705724 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OLYMPUS DEVICE DID NOT MALFUNCTION DURING ANY OF THE PROCEDURES DESCRIBED IN THE LITERATURE ARTICLE. IN ADDITION, AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE ADVERSE EVENTS.

  Patient problems: Air Embolism; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bronchospasm; Dyspnea; Fever; Fibrosis; Headache; Hemoptysis; Hemorrhage/Blood Loss/Bleeding; Hypoxia; Pleural Empyema; Pneumothorax; Respiratory Failure; Sore Throat; Syncope/Fainting; Unspecified Infection; Vomiting

  MAUDE report 17911520 ↗
• DeathOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: NO OLYMPUS DEVICE CAUSE OR CONTRIBUTE TO ANY OF THE PATIENT ADVERSE EVENTS DESCRIBED IN THIS LITERATURE. NO OLYMPUS DEVICE MALFUNCTION DURING ANY PROCEDURE DESCRIBED IN THIS LITERATURE. BIOPSY WAS NOT PERFORMED ON TWO PATIENTS WHO DIED FROM PROCEDURE-RELATED CAUSES.

  Patient problems: Air Embolism; Fibrosis; Pneumonia; Respiratory Failure; Septic Shock

  MAUDE report 17911500 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL FORCEPS BIOPSY: A RETROSPECTIVE BICENTRIC STUDY USING THE OLYMPUS 1.5 MM MINI-FORCEPS." LITERATURE SUMMARY: WHEN EVALUATING MEDIASTINAL/HILAR LYMPHADENOPATHY (LAD) OR MASSES, GUIDELINES RECOMMEND ENDOBRONCHIAL ULTRASOUND (EBUS)-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) AS AN INITIAL TECHNIQUE FOR TISSUE ANALYSIS AND DIAGNOSIS. HOWEVER, OWING TO THE SMALL SAMPLE SIZE OBTAINED BY NEEDLE ASPIRATION, ITS DIAGNOSTIC YIELD (DY) IS LIMITED. EBUS TRANSBRONCHIAL FORCEPS BIOPSY (TBFB) USED AS A COMPLIMENTARY TECHNIQUE TO EBUS-TBNA MIGHT ALLOW FOR BETTER HISTOPATHOLOGICAL EVALUATION, THUS IMPROVING DY. IN THIS RETROSPECTIVE BICENTRIC STUDY, WE ASSESSED THE DY AND SAFETY OF AN EBUS-GUIDED 1.5 MM MINI-FORCEPS BIOPSY COMBINED WITH EBUS-TBNA FOR THE DIAGNOSIS OF MEDIASTINAL/HILAR LAD OR MASSES COMPARED TO EBUS-TBNA ALONE. IN TOTAL, 105 PATIENTS WERE ENROLLED. THE OVERALL DY WAS 61.9% AND 85.7% FOR TBNA ALONE AND EBUS-TBNA COMBINED WITH EBUS-TBFB, RESPECTIVELY (P < 0.001). WHILE THE COMBINED APPROACH WAS ASSOCIATED WITH A SIGNIFICANTLY HIGHER DY FOR LUNG CANCER DIAGNOSIS (97.1% VS. 76.5%, P = 0.01

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Respiratory Failure

  MAUDE report 15401623 ↗