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

Model Number NA-201SX-4021

Device Problem Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The subject device presented in the article was not returned for evaluation.Review of the complaint database found no complaint or report of an adverse event related to the event detailed in this article.We were unable to review the device history record as no lot number was provided.All products are inspected prior to release from the manufacturing site.As a precautionary measure, the manual states : do not coil the insertion portion with a diameter of less than 150 mm.Doing so could damage the instrument.Do not insert this instrument when the endoscope is angulated.This could damage the endoscope and /or this instrument.Turn the up/down angulation control lever to the neutral position to straighten the endoscope before the insertion of this instrument into the endoscope.Otherwise, this could damage the endoscope and/or this instrument.Do not force the instrument if resistance to insertion is encountered.Reduce the angulation of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument.If you feel excessive resistance while operating the needle, do not push the needle slider forcibly.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the instrument and/or endoscope.

Event Description

During a proactive post market surveillance literature review, an article titled "an expectorated "stent" an unexpected complication of ebus-tbna", *journal of bronchology & interventional pulmonology: july 2017-volume 24 - issue 3 -p250-252¿ was found and reviewed.The abstract details an incident in which a (b)(6) year old man, two days post endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna), reported that he had coughed up a ¿stent.¿ the expectorated device was determined to be a spring-like structure that was a part of the single-use vizishot ebus-tbna (na-201sx-4021) needle assembly.The clinician, after positioning the needle catheter in view and advancing the needle through the working channel, experienced unexpected resistance.The catheter was withdrawn and it was noted that the needle had been inadvertently advanced within the working channel.The needle was repositioned and the procedure completed.There was no reported bleeding, pain, or additional medical or surgical intervention required.The user facility reported, during sterilization and processing of the bronchoscope there was reported damage to the inner working channel.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9415894
• MDR Text Key: 219788529
• Report Number: 8010047-2019-04165
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-201SX-4021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2019
• 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
• Patient Age: 52 YR