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

Model Number	NA-U401SX-4022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Hemorrhage/Blood Loss/Bleeding (1888); Hypoxia (1918); Perforation of Vessels (2135)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported in the literature article titled ¿comparison of ultrasonic bronchoscope uc290f and uc260fw at our hospital¿; patients experienced adverse events during or after procedures using olympus devices.Case with patient identifier (b)(6) reports na-403d-2021.Case with patient identifier (b)(6) reports bf-uc260fw.Case with patient identifier (b)(6) reports bf-uc290f.Case with patient identifier (b)(6) reports na-u401sx-4022.Background: the ultrasonic bronchoscope is effective for collecting specimens of lesions in contact with the central airway, and we have introduced the ultrasonic bronchoscope uc290f since september 2020.We report this because we examined the comparison with the uc260fw that was used until then.Method: from november 2019 to november 2021, 177 cases using an ultrasonic bronchoscope were retrospectively examined at our hospital.Results: median age 71 years (24-84 years).125 males and 52 females.Uc290f 49 cases, biopsy needle visishot2 22g 48 cases, visishot 19g 1 case, average number of biopsies 4.1 times.Uc260fw 128 cases, biopsy needle visishot2 22g 116 cases, cook22g l 1 case, cook25g 1 case, average number of biopsies 4.1 times.The biopsy site was uc290f lymph node lesions in # 718 cases, # 4r17 cases, # 11 6 cases, # 2r 1 case, # 4l 1 case, # 10 1 cases, # 13 1 cases, lung lesions were in 3 cases on the dorsal side of the middle trunk and 1 case on the ventral side of the left main bronchus.Lymph node lesions of uc260fw were # 760 cases, # 4r32 cases, # 11 10 cases, # 4l7 cases, # 10 6 cases, # 2r5 cases, # 2ll cases, lung lesions were found in 6 cases on the dorsal side of the middle trunk and 1 case on the left main bronchus bifurcation.The diagnosis rate is uc290f 77.6%, uc260fw 79.7%.Complications were uc290f with backflow during puncture in 1 case, mediastinal abscess in 1 case, arrhythmia in 1 case, uc260fw with hypoxia in 2 cases, backflow during puncture in 1 case, accidental puncture of blood vessels in 1 case, and bleeding in 1 case.Conclusion: there was no significant difference in the diagnosis rate and complications.Further cases will be collected and presented.There is no report of any olympus device malfunction reported in any procedure described in this literature.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information was added to the following fields: d4, h6, h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• Common Device Name: 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: 14642264
• Report Number: 8010047-2022-09709
• Device Sequence Number: 5693594
• Product Code: FCG
• UDI-Device Identifier: 04953170388323
• UDI-Public: 04953170388323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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-U401SX-4022
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/08/2022
• 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