MAUDE Adverse Event Report: OLYMPUS RESPIRATORY AMERICA SINGLE USE ASPIRATION NEEDLE

Model Number NA-U402SX-4019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemoptysis (1887)

Event Type  Injury  

Manufacturer Narrative

This complication in the journal article was reviewed.Product not available for evaluation and lot information not made available to manufacturer to perform review.Risk analysis and labeling reviewed.Hemoptysis is an anticipated potential complication and the incidence is within the anticipated occurrence rate in the risk analysis.Device is no longer manufactured and distributed.Therefore, no corrective actions required at this time.

Event Description

In the complications section of an article titled "endobronchial ultrasound-guided transbronchial needle aspiration with a 19-g needle device" published in the journal of bronchology and interventional pulmonology (j bronchol intervent pulmonol 2018;25:218¿223) the following was included: "complications in 1 case, significant hemoptysis (<50 ml) was noted immediately after withdrawal of the ebus bronchoscope.This was managed by reinsertion of the standard bronchoscope to suction retained blood in the airway, after which no active bleeding was noted.".

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Type of Device: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS RESPIRATORY AMERICA; 6675 185th ave ne; redmond WA 98052
• Manufacturer Contact: sophia rubalcaba ; 6675 185th ave ne; redmond, WA 98052 ; 4256365470
• MDR Report Key: 10040996
• MDR Text Key: 196942907
• Report Number: 3004450998-2020-00007
• Device Sequence Number: 1
• Product Code: KTI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K163469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NA-U402SX-4019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2020
• 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 Sequence Number: 1