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

Model Number NA-201SX-4022

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During an endobronchial ultrasound-guided trans- bronchial needle aspiration, the subject device was used.The doctor thought that the needle adjuster lever was locked but the needle adjuster of the subject device was unlocked and the needle tube of the subject device was extended more than the user expected.The needle tube penetrated the lymph node of the patient.The intended procedure was canceled and the user performed a computed tomography.The user confirmed that the penetration had no effect on the patient.The patient has been received a follow-up examination.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The inner part of the needle adjuster lever was dented.The needle adjuster was fixed firmly when the adjuster was locked at the appropriate position.There were no other abnormalities in the adjustment function of the penetration depth of the needle.The manufacturing record was reviewed and found no irregularities.Based on the reported information and the evaluation result of the subject device, omsc presume that the event (the protrusion of the needle tube more than the user expected) occurred due to the following occurrence mechanism.The needle adjuster lever which locks or unlocks needle adjuster was pushed a direction to lock at an inappropriate position, causing the inner part of the needle adjuster lever was dented.As a result, the needle adjuster was not locked.The above device handling has warned in the instruction manual as follows.If you feel excessive resistance while operating the needle adjuster lever, release the needle adjuster lever once and fix it again.Otherwise, it could damage the needle adjuster lever and patient injury, such as perforation, bleeding, or mucous membrane damage could result.Before pushing the needle slider, confirm that the needle adjuster is fixed firmly.Be sure to firmly fix the needle adjuster.Otherwise, it could cause excess extension of the needle from the distal end of the sheath and perforation, bleeding, mucous membrane damage may result.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Type of Device: 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: 8854260
• MDR Text Key: 153065860
• Report Number: 8010047-2019-02813
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NA-201SX-4022
• Device Lot Number: 87K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other