MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX

Model Number NA-U401SX-4022

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

Patient Problems Inflammation (1932); No Code Available (3191)

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 serial 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 is no description of the device's malfunction.

Event Description

On november 26, 2020, olympus medical systems corp.(omsc) received the literature titled "a case of acute bacterial pericarditis suddenly onset two weeks after ultrasonography-guided needle biopsy".This study was conducted endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) for pathological diagnosis on a (b)(6) years old man.In the literature, it was reported that anterior chest pain and pericardial fluid retention in 14 days after the ebus-tbna procedure.The patient was hospitalized.Streptococcus gordonii was detected in the results of culturing pericardial fluid and was diagnosed as acute bacterial pericarditis.And, it was reported that bacterial pericarditis associated with bus-tbna was presumed from the clinical course.Based on the available information, detailed information of the subject device was not provided, and there is no description of the relationship between the events and the subject device.However, omsc assumes that the reported event might be related to the subject device since the subject device was used for ebus-tbna.Therefore omsc assumes that hospitalized bacterial pericarditis might be a reportable serious injury.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) for the hospitalized bacterial pericarditis with the subject device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• 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: 10963156
• MDR Text Key: 223070881
• Report Number: 8010047-2020-09974
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NA-U401SX-4022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR