BIOPSY FORCEPS FB-15C-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170029530), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FEASIBILITY OF MODIFIED ENDOBRONCHIAL ULTRASOUND-GUIDED INTRANODAL FORCEPS BIOPSY: A RETROSPECTIVE ANALYSIS." THE RETROSPECTIVE STUDY WAS TO ASSESS THE FEASIBILITY OF THE MODIFIED EBUS- INTRANODAL FORCEPS BIOPSY (IFB) TECHNIQUE, WHICH COMBINES STANDARD-SIZED FORCEPS WITH STANDARD ENDOBRONCHIAL ULTRASOUND (EBUS) TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) EQUIPMENT. A TOTAL OF 195 PATIENTS WERE INCLUDED. IFB WAS TECHNICALLY SUCCESSFUL IN 177 OF 195 CASES (90.8%). THE DIAGNOSTIC ACCURACY WAS 99.5% (193 OF 194 CASES). ONE PATIENT WAS LOST TO FOLLOW-UP. UNIVARIABLE ANALYSES DID NOT IDENTIFY ANY FACTORS INVOLVED IN TECHNICAL IFB FAILURE. AMONG THE DIAGNOSED CASES, THREE (1.5%) WERE DIAGNOSED. THE MEDIAN (RANGE) HISTOLOGICAL SCORES OF TBNA AND IFB SPECIMENS WERE 1.50 (0¿2) AND 1.67 (0¿2), RESPECTIVELY, WHICH WERE SIGNIFICANTLY DIFFERENT (P = 0.032). IN CONCLUSION, MODIFIED EBUS-IFB, COMBINING STANDARD-SIZED FORCEPS AND THE USUAL EQUIPMENT FOR EBUS TBNA, IS FEASIBLE WITH FEW MAJOR COMPLICATIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS¿ PNEUMONIA - 1 PATIENT PNEUMOTHORAX REQUIRING THORACIC DRAINAGE - 1 PATIENT MINOR BLEEDING - 25 PATIENTS THI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumonia; Pneumothorax

  MAUDE report 16765412 ↗