MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BIOPSY FORCEPS

Model Number	FB-231D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Event or Problem Description
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).

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 20705628
• Report Number: 2429304-2024-0000463
• Device Sequence Number: 15466647
• Product Code: EOQ
• UDI-Device Identifier: 04953170158209
• UDI-Public: 04953170158209
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2024
• Report Date (Section F): 10/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FB-231D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/22/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BF-MP190F, BRONCHOVIDEOSCOPE, SN -UNK.; BF-P190, BRONCHOVIDEOSCOPE, 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown