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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX Back to Search Results
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.
 
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Brand NameSINGLE USE ASPIRATION NEEDLE NA-U401SX
Type of DeviceSINGLE 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 Key10963156
MDR Text Key223070881
Report Number8010047-2020-09974
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
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 Received12/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNA-U401SX-4022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2020
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

Patient Treatment Data
Date Received: 12/07/2020 Patient Sequence Number: 1
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