MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE

Model Number NA-201SX-4022

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

Patient Problems Fever (1858); Unspecified Infection (1930); Sepsis (2067); Confusion/ Disorientation (2553)

Event Date 03/31/2018

Event Type  Death  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional information.

Event Description

It is reported in the literature titled ¿feasibility of ebus-tbna for histopathological and molecular diagnostics of nsclc¿a retrospective single-center experience¿, complications occurred in 3.6% (5/140) of performed ebus-tbna procedures using an evis exera ii ultrasonic bronchofibervideoscope, and two different sized single use aspiration needles.Study aim: to evaluate the adequacy and sufficiency of ebus-tbna cytology specimen for subtyping, molecular genetic profiling, and analysis of pd-l1 in a consecutive series of patients diagnosed with nsclc.Study method: medical record data extraction over a 15-month period of patients examined with bronchoscopy with ebus-tbna for suspected or known lung cancer.All patients had been previously examined with computed tomography of the chest (chest ct), supplemented by positron emission tomography-computed tomography (pet ct) scan when indicated, and had confirmed pulmonary mass and/or mediastinal lymphadenopathy.Subsequently, conventional or advanced flexible bronchoscopies with ebus-tbna procedures were performed.Results: during the study period there were 806 ebus procedures performed on 765 patients, aiming to diagnose and/or stage suspect or known lung cancer.296 diagnostic ebus-tbna, 260 staging ebus-tbna, and 250 radial ebus procedures were conducted.In patients with concomitant mediastinal lymphadenopathy and lung lesions reachable by radial ebus, linear ebus was performed immediately after the radial ebus, during the same bronchoscopy procedure.The outcomes of the bronchoscopy with radial and/or linear ebus procedures resulted in diagnosing lung cancer in 209/765 (27%), 174 with nsclc, 26 with small cell lung cancer (sclc), and 9 with carcinoids.In 132 of 174 nsclc patients (76%), we detected cancer cells in the fine needle aspirate from ebus-tbna.These patients thus fulfilled the criteria for being included in a consecutive manner in our cohort.Conclusions: our results confirm bronchoscopy with ebus-tbna as a safe, and minimally invasive procedure of first choice with a central role in the demanding diagnostic and staging workout for lung cancer.Although more data is needed on the utility of ebus-tbna cytology specimen for mps and pd-l1 analysis, ebus cytology aspirates appear to be reliable for diagnosing and subtyping nsclc and abundantly for treatment predictive molecular testing.Complications occurred in 3.6% (5/140) of performed ebus-tbna procedures.Postprocedural minor hemoptysis was described in one patient.Two patients reported mild fever a few days after the procedure that resolved spontaneously without any medical intervention.Two patients were hospitalized, one due to sepsis and the other one for mediastinitis, both recovered fully after antibiotic treatment.One patient died 3 days after ebus-tbna.The patient was a (b)(6) male with copd who presented with stage iv lung adenocarcinoma and was admitted to the hospital prior to ebus-tbna due to severe dyspnea.The ebus-tbna procedure was uncomplicated, but the patient became disoriented the next day.The patient rapidly deteriorated despite the administration of broad-spectrum antibiotics, became unconscious, and died within 72 hours of ebus-tbna.The scenario was attributed to sepsis even though the blood culture was negative.A possible differential diagnosis could have been paraneoplastic encephalitis.However, the family strongly opposed an autopsy, and the procedure was not performed.There was no report of olympus device malfunction in any procedure described in this literature.Case with patient identifier (b)(6) reports the na-201sx-4022 used in the procedures.Case with patient identifier (b)(6) reports the na-401sx-4022 used in the procedures.Case with patient identifier (b)(6) reports the bf-uc180f used in the procedures.

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 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 event 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: SINGLE USE ASPIRATION NEEDLE
• Type of Device: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13664653
• MDR Text Key: 286553938
• Report Number: 8010047-2022-03933
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170389887
• UDI-Public: 04953170389887
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NA-201SX-4022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention; Death