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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 Fever (1858); Unspecified Infection (1930); Sepsis (2067); Confusion/ Disorientation (2553)
Event Date 04/01/2018
Event Type  Death  
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) year-old 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 c22053391 reports the na-201sx-4022 used in the procedures. Case with patient identifier c22053393 reports the na-401sx-4022 used in the procedures. Case with patient identifier c22053352 reports the bf-uc180f used in the procedures.
 
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.
 
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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 Key13664652
MDR Text Key286553749
Report Number8010047-2022-03932
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K160098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Literature,Health Professional
Reporter Occupation
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 Received03/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNA-U401SX-4022
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/28/2022
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 Treatment Data
Date Received: 03/03/2022 Patient Sequence Number: 1
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