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 Problem Hemothorax (1896)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there was no description of the device's malfunction.On october 28th, the medical safety officer, who have the medical license, reviewed as bellow.The hemothorax might be serious injury because the patient was required additional hospitalization after ebus-tbna.In addition, it estimated that the patient was high risk because he had each cancer in the bronchus and the colon.

Event Description

On october 25, olympus medical systems corp.(omsc) received the literature "hemothorax after endobronchial ultrasound-guided transbronchial needle aspiration¿.The purpose of the literature was to report a case of hemothorax after endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) in a patient with a right upper lobe mass.The ebus-tbna was performed using a bronchoscope (bf-uc160f) and a needle (na-201sx-4022).In the literature, it was reported a case of hemothorax 24 hours after ebus-tbna as bellow.¿twenty-four hours after the procedure the patient complained of increasing dyspnea and right-sided pleuritic chest pain.Hemoglobin fell to 49 g/l and a ct scan showed a high attenuation right-sided pleural effusion (fig.2).A diagnostic thoracocentesis revealed a bloody pleural effusion with pleural fluid hematocrit >50% of the peripheral blood hematocrit (0.18 vs.0.22) confirming that a hemothorax was present, and a chest tube was placed with complete recovery within 3 days.¿ afterward, understanding a colonoscopy, he was diagnosed with advanced, stage iv lung adenocarcinoma, and synchronous sigmoid adenocarcinoma arising from tubulovillous adenoma.Chemotherapy was started and multiple transfusions were required due to anemia and thrombocytopenia secondary to hypersplenism.The outcome of the patient was death 2 months after diagnosis.On october 28th, the medical safety officer, who have the medical license, reviewed as bellow.The hemothorax might be serious injury because the patient was required additional hospitalization after ebus-tbna.In addition, it estimated that the patient was high risk because he had each cancer in the bronchus and the colon.Based on the available information, a direct relationship between the olympus product and these complications could not be determined.However, 1 case of a hemothorax might be serious injury.This is the report regarding 1 case of a hemothorax that may have required additional hospitalization.

• 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: 12768090
• MDR Text Key: 280450280
• Report Number: 8010047-2021-14245
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170381928
• UDI-Public: 04953170381928
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NA-201SX-4022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male