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

Model Number	NA-201SX-4021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Bronchospasm (2598)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to report the user's experiences and investigation findings.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: no malfunction of any olympus device was reported in any procedure described in this article.From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.
Event or Problem Description
It is reported in the literature titled ¿the diagnostic yield of endobronchial ultrasound transbronchial needle aspiration (ebus-tbna) in respiratory compromised patients under general anesthesia,¿ patients experienced adverse events after procedures using multiple olympus devices.Case with patient identifier (b)(6) reports the bf-uc180f used in the procedures.Case with patient identifier (b)(6) reports the na-201sx-4021 used in the procedures.Background: endobronchial ultrasound transbronchial needle aspiration (ebus-tbna) is a frequently used method for obtaining tissue samples for the diagnosis of various respiratory conditions, including lung cancer staging.In most cases, ebus-tbna is performed under moderate sedation (ms).However, in cases of respiratory compromised patients, if this procedure is performed, it is conducted under general anesthesia (ga).Objectives: to assess the diagnostic yield of ebus-tbna among respiratory compromised patients.Methods: data of consecutive patients (n=191) who underwent ebus-tbna at our medical center between january 2019 and december 2019 were retrospectively analyzed.Respiratory compromised patients underwent ga and patients without respiratory compromise were mostly moderately sedated (ms).Characteristics, diagnostic yield, and complication rates were compared.Results: diagnostic yield was similar between the two sedation modes (89% in ga group and 78% in the ms group, p = 0.11).The number of total samples obtained per procedure was significantly higher in the ga vs.The ms group (4.1 ± 2.1 vs.2.1 ± 1.33, p < 0.01).The overall complication rate was 13% and 20.9% in the ga vs.The ms groups, respectively (p = 0.14), with the most frequent complication being minor bleeding.Interestingly, while the number of brushings, bronchoalveolar lavage, and endobronchial biopsy were similar, the percent of subjects who underwent transbronchial biopsy was significantly higher in the ga group (49% vs.24.2%, p < 0.01).Conclusions: ebus-tbna performed under ga among respiratory compromised patients is safe and has similar diagnostic yield to that of patients without a respiratory compromise.There were no major complications or escalation of care in either group.The overall complication rate was 13% and 20.9% in the ga vs.The ms groups, respectively ( = 0.14).The most frequent complication was minor bleeding (11% vs.12.1%, respectively, = 0.81).Other complications included transient hypoxemia (o2 saturation < 90%), hypotension (systolic blood pressure < 90 mmhg) and bronchospasm episodes (1% in both groups, = 0.94), which resolved completely following bronchodilator administration.Same day discharge rate was significantly higher among the ms group as compared with that of the ga group ( < 0.01).There is no report of olympus device malfunction reported in any procedure described in this study.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; tokyo-to, hachioji-shi 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: 15087732
• Report Number: 8010047-2022-12098
• Device Sequence Number: 4035208
• Product Code: FCG
• UDI-Device Identifier: 04953170381911
• UDI-Public: 04953170381911
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NA-201SX-4021
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown