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

Model Number NA-U402SX-4019

Device Problem Device Slipped (1584)

Patient Problem Perforation (2001)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

Follow-up information indicates that the stent that was placed over the perforation has been removed and the patient left the hospital.

Event Description

The fixed tube of the ebus neddle has been slipped in the working channel of the bf-uc180f (s/n (b)(4) will also be send to our workshop) and it wasn't possible to control the needle by the user.The needle was pushed out, and the tubus has been slipped, the bronchus of the patient has been perforated.The patient has been transferred to the (b)(6) and the additional examination (ct thorax with km) for clarification of a mediastinal emphysema has been executed.The diagnostic finding of the left bronchus has been controlled by setting a stent.The stent will be removed in the future.

• 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: cyndy adams ; 6675 185th ave ne; redmond, WA 98052 ; 425636-545
• MDR Report Key: 6985906
• MDR Text Key: 90509543
• Report Number: 3004450998-2017-00004
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NA-U402SX-4019
• Device Lot Number: .
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: No
• 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