DISPOSABLE BIOPSY FORCEPS FB-241KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170158087), received between Nov 15, 2020 and Sep 15, 2022 — 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. How this data works · Data updated Oct 13, 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.

• 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 15429337 ↗
• 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 15428134 ↗
• InjuryNov 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE RECEIVED THE FOLLOWING REPORT. *WHEN THE ENDOSCOPY WAS PERFORMED, THE BIOPSIES LED HEMORRHAGE WHILE THE PATIENT'S MUCOUS MEMBRANE WAS HEALTHY WITH NO ANTICOAGULANT TREATMENT. ONE OF THE HEMORRHAGIC BIOPSIES RESULTED IN AN OVAL HEMATOMA OF 12MM. THE PATIENT WAS DISCHARGED ONCE, THEN ADMITTED TO THE EMERGENCY ROOM IN THE EVENING OF THE DAY FOR (B)(6). THE PATIENT IS STILL HOSPITALIZED. IT IS UNCLEAR IF THE BIOPSY FORCEPS CONTRIBUTED TO THESE EVENTS.

  Patient problems: Hematoma

  MAUDE report 10841641 ↗