MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER

Model Number EU-ME1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemoptysis (1887); Pneumonia (2011); Pneumothorax (2012); Respiratory Failure (2484)

Event Date 08/30/2019

Event Type  Injury  

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.This report has been submitted by the importer under this mdr report number 2429304 - 2022 - 00059.

Event Description

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-specific soc with ca-tbfb yielded gains that varied by diagnosis.Diagnostic yields of soc and its supplementation with catbfb were 91.8% and 93.4% (p [.50) of the 61 patients diagnosed with solid-organ malignancy, 62.7% and 94.9% (p <.001) of the 59 patients diagnosed with sarcoidosis, and 62.5% and 93.8% (p [.042) of the 16 patients diagnosed with lymphoma, the.For each disease process, specimens obtained with ca-tbfb exhibited statistically higher quality.Conclusions.We suggest that relative to soc, ca-tbfb improves diagnostic yield for sarcoidosis and lymphoma while providing uniformly better tissue quality and cellularity.We propose a protocol for use of this innovative technique.The following adverse events were reported by the authors: pneumomediastinum within 48 hours, pneumonia within 10 days, pneumothorax within 48 hours, respiratory failure, hemoptysis within 1 wk.This article includes 5 reports as follows: (b)(6): bf-uc180f, (b)(6): eu-me1, (b)(6): na-201sx-4022, (b)(6): kd-31c-1, (b)(6): fb-241k.This report is 2 of 5 for (b)(6): eu-me1.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.New information added to the following fields: b5, h6, h10.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.No malfunctions were reported.Olympus will continue to monitor field performance for this device.

Event Description

The author responded to our request for additional information as follows: the study took a retrospective look at procedures which were done for a variety of clinical indications.Similarly, most of these patients had multiple other procedures performed during the cases.It is impossible to tease out which aspect of each procedure caused any of the complications.For example, the 4 patients with pneumothorax in the study all underwent transbronchial biopsies, for which pneumothorax is a known complication.The olympus device serial/lot numbers are not available.None of the events were caused by olympus devices directly, but by the procedure using them.Pneumothoraces for example occur 2-6% of the time transbronchial biopsies are taken and were an expected outcome.Pneumomediastinum can occur during any ebus procedure.The other events are likely complications of the overall procedure in patients with advanced disease.None of these were felt to be caused directly by the olympus products.No additional information available regarding medical/surgical intervention.

• Brand Name: UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER
• Type of Device: UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15429443
• MDR Text Key: 300041094
• Report Number: 3002808148-2022-02064
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 04953170263255
• UDI-Public: 04953170263255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EU-ME1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNK LOT: NA-201SX-4022, KD-31C-1, FB-241K.; UNK SERIAL: BF-UC180F.
• Patient Outcome(s): Other