FDA Adverse Event Injury Summary report: N

EVIS EXERA III BRONCHOVIDEOSCOPE

MDR report key: 20705639 · Received November 18, 2024

Report

Report Number
2429304-2024-0000461
Event Type
Injury
Date Received
November 18, 2024
Report Date
November 18, 2024
Manufacturer
AIZU OLYMPUS CO., LTD.
Product Code
EOQ
UDI-DI
04953170342110
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
NY, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

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 AFTER EMPLOYMENT OF THE ULTRATHIN BRONCHOSCOPE. LOGISTIC REGRESSION MODELS WERE EMPLOYED TO ASSESS THE INDEPENDENT ASSOCIATIONS OF THE MOST IMPACTFUL VARIABLES. RESULTS: A TOTAL OF 322 PATIENTS WERE INCLUDED IN THIS STUDY. THE MEDIAN OF THE LONG AXIS DIAMETER WAS 2.2 CM AND THE MEDIAN DISTANCE OF THE CENTER OF THE LESION FROM THE VISCERAL PLEURAL SURFACE WAS 1.9 CM. OVERALL DIAGNOSTIC YIELD WAS 81.3% AFTER EMPLOYMENT OF THE ULTRATHIN BRONCHOSCOPE, WITH MORE DETECTION OF CONCENTRIC REBUS VIEWS (93% VS. 78%, P < 0.001). SENSITIVITY FOR DETECTING MALIGNANCY ALSO INCREASED FROM 60.5% TO 74.7% (P = 0.033) AFTER INCORPORATING THE ULTRATHIN SCOPE INTO PRACTICE, WHILE BRONCHUS SIGN AND PERIPHERAL LOCATION OF THE LESION WERE NOT FOUND TO AFFECT DIAGNOSTIC YIELD. CONCENTRIC REBUS VIEW, SOLID APPEARANCE, UPPER/MIDDLE LOBE LOCATION AND LARGER SIZE OF THE NODULES WERE FOUND TO BE INDEPENDENT PREDICTORS OF SUCCESSFUL ACHIEVEMENT OF DIAGNOSIS AT BRONCHOSCOPY. INTERPRETATION: THIS STUDY DEMONSTRATES A HIGH DIAGNOSTIC YIELD OF BIOPSY OF LUNG LESIONS ACHIEVED BY UTILIZATION OF THIN AND ULTRATHIN BRONCHOSCOPES. DIRECT VISUALIZATION OF SMALL PERIPHERAL AIRWAYS WITH SIMULTANEOUS REBUS CONFIRMATION TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: EVENT 1- PNEUMOTHORAX (3 PATIENTS). EVENT 2- AIRWAY BLEEDING (5 PATIENTS).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2112000 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-P190 04953170342110

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Hospitalization| R BF-MP190F, BRONCHOVIDEOSCOPE, SN -UNK,| DISPOSABLE BIOPSY FORCEPS. FB-231D, SN-UNK,| NA-1C-1, ASPIRATION NEEDLE, SN-UNK| NA-403D-2021 SINGLE USE ASPIRATION NEEDLE, SN-UNK| SINGE USE BIOPSY FORCEPS, FB-433D, SN-UNK| UM-S20-17S, ULTRASONIC PROBE, SN-UNK,