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

Model Number	NA-201SX-4022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On may 31, 2021, olympus medical systems corp.(omsc) received the literature titled "learning endobronchial ultrasound transbronchial needle aspiration - a 6-year experience at a single institution".This study was conducted on a total of 711 ebus-tbna procedures for 635 patients from 2007 to 2013.In the literature, it was reported that one patient was admitted for a pneumothorax requiring drainage one week after the procedure.The convex probe ebus (bf-uc160f-ol8, bf-uc180f-ol8) and dedicated 22 or 21 gauge needles (na-201sx-4021, na-201sx-4022) were used for ebus-tbna.Based on the available information, reported pneumothorax was not reported in a direct relationship with the olympus products.However, omsc assumes that the pneumothorax might be related to the subject device since the subject device was used for the procedure.And, omsc assumes that the pneumothorax with hospitalization might be caused or contributed to a death or serious injury.Therefore, omsc assumes that the pneumothorax was an adverse event to submit.Based on the available information, specific information on the subject device and the patient were not provided.There is no description of the device's malfunction.Omsc will submit one medical device reports (mdr) of the subject device for the pneumothorax.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• 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
• MDR Report Key: 12030399
• Report Number: 8010047-2021-07740
• Device Sequence Number: 4751799
• Product Code: FCG
• UDI-Device Identifier: 04953170389900
• UDI-Public: 04953170389900
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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: No Information
• Device Model Number: NA-201SX-4022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention