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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE Back to Search Results
Model Number NA-201SX-4022
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pneumonia (2011); Sepsis (2067)
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 jun 12, 2021, olympus medical systems corp. (omsc) received the literature titled "risks and benefits in treatment of mediastinal abscess by endobronchial ultrasound-guided transbronchial needle aspiration". This study was conducted on the endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) for mediastinal abscess patient. In the literature, it was reported as follows; this study aims to report a case of mediastinal abscess with complications of pneumonia and sepsis caused by ebus-tbna but subsequently treated by ebus-tbna successfully. A (b)(6) year-old man presented with transient high fever (39. 38c) in conjunction with a six-month-long history of dry cough, chest computed tomography (ct) showed a non-enhancing mass in the subcarinal region. Ebus scan (cp-ebus) demonstrated an approximately 23. 4 * 20. 0 mm sized heterogeneous, hypoechoic, cystic lesion in the subcarinal region. Tbna was then applied and roughly 11 ml of yellowish mucopurulent material was then aspirated using a dedicated 22-gauge needle (na-201sx-4022). The microbial test from the initial ebustbna specimen of the lesion showed all negative results. Despite recommending inpatient treatment for further workup, post-procedure the patient selected to leave the hospital but returned to the hospital shortly thereafter on account of chest tightness, confusion, and cold sweats. In the emergency department, a chest ct scan revealed bilateral pneumonia, and he was diagnosed with sepsis. Again, the site was aspirated and approximately 15 ml of yellowish material was obtained. The second culture revealed candida albicans. The candida could potentially be a contaminant from the oral cavity and was transferred into the abscess cavity at the initial ebus-tbna. Maybe that's why culture was positive in puncture fluid at the second time of ebus-tbna. So the history of fever and cough may suggest subcarinal lymphadenitis gradually developed into a mediastinal abscess, and lesion stimulated adjacent trachea causes a dry cough. From the chest ct scan, we attributed bilateral pneumonia to pus gushed through the needle route into the dorsal airway when the patient coughed during the ebus tbna procedure, and rapid absorption of pus toxins in the lung led to sepsis. Omsc assumes that bilateral pneumonia led to sepsis was a serious adverse event that causes or contributes to a death or serious injury due to needing systemic antifungal treatment. This study was reported that the candida could potentially be a contaminant from the oral cavity and was transferred into the abscess cavity at the initial ebus-tbna. And, bilateral pneumonia to pus gushed through the needle route into the dorsal airway, and rapid absorption of pus toxins in the lung led to sepsis. Based on the available information, specific information on the subject device was not provided. There is no description of the device's malfunction. Omsc will submit 2 medical device reports (mdr) of the scope and the needle. This report is 1of 2. This report is regarding the serious injury (bilateral pneumonia led to sepsis) that might be related to the subject device (needle).
 
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Brand NameSINGLE USE ASPIRATION NEEDLE
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 Key12230933
MDR Text Key267560320
Report Number8010047-2021-09404
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K050503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNA-201SX-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 Received07/12/2021
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 Unkown

Patient Treatment Data
Date Received: 07/27/2021 Patient Sequence Number: 1
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