MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES BRONCHOFIBERSCOPE

Model Number	BF-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoxia (1918); Pneumothorax (2012)
Date of Event	11/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "feasibility and safety of transbronchial lung cryobiopsy for diagnosis of acute respiratory failure with mechanical ventilation in intensive care unit." background: acute hypoxemic respiratory failure is common in intensive care units (icus).Lung biopsies may be required to make a definitive diagnosis in patients with unknown etiologies.The feasibility of transbronchial lung cryobiopsy is undetermined in patients with respiratory failure in the icu.Methods: patients who underwent bronchoscopy examinations with transbronchial lung cryobiopsy (tblc) between july 2018 and december 2019 were retrospectively analyzed through medical chart review.The procedures were performed by well-experienced interventional pulmonologists.Results: ten patients underwent bronchoscopy examinations with tblc in the icu at chang gung memorial hospital during the study period.In all patients, the diagnosis was made via pathological analysis.One patient developed pneumothorax and required chest tube placement after the procedure.None of the patients had bleeding requiring blood transfusion, and no deaths were directly related to the procedure.Conclusions: tblc is a feasible technique to obtain lung pathology in patients with acute respiratory diseases of unknown etiologies.While the complication rate may be acceptable, the procedure should be performed by experienced interventional pulmonologists.However, airway blockers and fluoroscopy are highly recommended when used according to the current guideline.We do not encourage tblc to be performed without having airway blockers available at the bedside.Although 5 patients died during hospitalization, it is not related to cryobiopsy or its equipment.Per the article, five patients (50%) died during hospitalization in the icu because of persistent hypoxemia and multi-organ failure.The deaths occurred at a mean of 18.2 ± 10.1 days after cryobiopsy.The other five patients (50%) were alive and discharged from the hospital at a mean of 22.4 ± 8.1 days after cryobiopsy.Two patients had a history of cancer; one had been diagnosed with lung adenocarcinoma, and the other had diffuse large b-cell lymphoma post-bone marrow transplantation.Type of adverse events/number of patients: death - 5 patients, fever - 2 patients (non-reportable), pneumothorax - 1 patient, hypoxemia - 1 patient.This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6) (bf-p240), (b)(6) (bf-40), (b)(6) (bf-p240), (b)(6) (bf-40).This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: OES BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16499832
• Report Number: 9610595-2023-03894
• Device Sequence Number: 20393286
• Product Code: EOQ
• UDI-Device Identifier: 04251725204150
• UDI-Public: 04251725204150
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K963033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: BF-40
• Device Catalogue Number: BF-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown