MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE

Model Number	NA-401D-1521
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/04/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus review the following literature titled "value of different bronchoscopic sampling techniques in diagnosis of sarcoidosis: a prospective study of 151 patients".Literature summary: this prospective study describes the value of different bronchoscopic sampling techniques in diagnosis of sarcoidosis.Of the 164 patients studied, 151 were finally diagnosed as sarcoidosis.Granulomas were demonstrated in 127 (84.2%) patients.The procedure was performed in the supine position by trans nasal (or oral) route by experienced faculty or by fellows under direct supervision, using a fiberoptic bronchoscope (bf-1t20 or bf-te2; olympus, japan; fb 19tv; pentax, japan).Ebb (at least 4 specimens) was performed with the standard biopsy forceps (fb15c; olympus) from the abnormal looking areas if any; or from secondary carinal areas.Transbronchial lung biopsies (at least 4 specimens) were obtained without fluoroscopy using the standard biopsy forceps (fb19c; olympus) from the site of maximal involvement on ct chest or from right lower lobe, if ct chest was normal.Three passes were attempted in each lymph node station using the conventional 21 g tbna needle (smooth shot; olympus) without an onsite cytopathologist.In some patients, ebus-tbna was performed using an ebus bronchoscope (bf-uc 180f; olympus) with a compatible ultrasound processor (eu-me1; olympus) at an ultrasonic frequency of 7.5mhz.Diagnostic yield of tblb, ebb, tbna, and ebus-tbna was 68.7%, 49.6%, 22.43%, and 57.1%, respectively.Cumulative yields of various procedures were: ebb+ tblb 81.4%; tblb+ tbna 73.7%; tbna+ ebb 62.9%; tblb+ ebb+ tbna 86.9%; and tblb+ ebb+ ebus-tbna 86.4%.In those with visible mucosal abnormalities, tblb+ ebb conferred the highest diagnostic yield (92.8%).Clinical findings or radiologic stage had no impact on diagnostic yield.One patient developed pneumothorax after bronchoscopy which was managed with simple needle aspiration.There was no episode of major hemorrhage.This study concludes that the tblb is an important tool in bronchoscopic diagnosis of sarcoidosis.If endobronchial abnormalities are seen during bronchoscopy, tblb with ebb gives the best results otherwise tblb combined with conventional tbna and ebb or ebus tbna are required to maximize the diagnostic yield.Type of adverse events/number of patients: pneumothorax: 1 patient.This article includes 5 reports: patient identifier (b)(6) (bf-te2), patient identifier (b)(6) (bf-1t20), patient identifier (b)(6) (biopsy forceps, fb-15c or fb-19c-1), patient identifier (b)(6) na-401d-1521 was selected as representative product for smooth shot, patient identifier (b)(6) (bf-uc180f).This report is 4 of 5 for patient identifier (b)(6) na-401d-1521 was selected as representative product for smooth shot.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or 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.Therefore, the root cause cannot be determined.This supplemental includes information added to b3 and g2.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15074969
• Report Number: 9614641-2022-00021
• Device Sequence Number: 5314560
• Product Code: GAA
• UDI-Device Identifier: 04953170196683
• UDI-Public: 04953170196683
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: CLASS1-EXMPT
• 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): 08/29/2022

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-401D-1521
• 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
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SERIAL UNK: BF-TE2 OR BF-1T20; SERIAL UNK: BF-UC180F, EU-ME1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown