MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX

Model Number NA-U401SX-4022

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

The reference device was returned to the service center for an evaluation.A visual inspection was performed on the returned device and found the stylet and its knob are not returned.There are 3 slight bends on the insertion portion but no damage on the metallic coil sheath.The needle is present but has minor biomaterial adhering on it.There were no missing fragments noted.To perform functional inspection, the handle was pushed down to extend the needle but could not retract the needle back inside.The handle felt loose and no resistance.Service center could not conclusively determine the cause of the reported complaint, the device will be forwarded to oem (original equipment manufacturer) for further investigation.As a preventive measure, the instruction manual for the device has directions for pre-procedure visual and functional inspection, including verification that the needle distal tip extends and retracts into the sheath.The instruction manual also has warnings and cautions for preventing breakage at the proximal end: ¿do not apply bending force to the handle section.¿ ¿if you feel excessive resistance while operating the needle, do not push the needle slider forcibly.¿ and ¿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¿.The instruction manual also advises, ¿always have a spare instrument available in case the primary instrument malfunctions.¿.

Event Description

Service center was informed that at the end of the procedure when trying to draw back needle, the handle moved and needle stayed.The shaft was came out and the needle was disconnected from the shaft.The procedure was completed using a similar device.

Manufacturer Narrative

The subject device, model na-u401sx-4022, lot # fr845237, was sent to the oem for investigation.The needle tube was detached from the needle slider and was kinked at the root of the boot.The part that fixes the needle tube was cut into two lengthwise to inspect the glue left on the part.The glue indicated the bonding of the needle tube to the part was appropriate.The device history record for the lot indicated no anomaly with the event-related items.The event description likely indicates the needle tube detached from the needle slider.The detachment of the needle tube was likely caused by the sequence of events below.1) the needle tube and the sheath were kinked when the device was taken out of the package or connected/disconnected to/from the endoscope.2) the kink locked the needle tube.3) the customer pulled the needle slider using excessive force to retract the locked needle tube.4) the excessive force used to pull the needle slider exceeded the strength of the glue bonding the needle tube.The needle tube was therefore detached from the needle slider.Per the device instructions for use: ·do not coil the insertion portion with a diameter of less than 150 mm.Doing so could damage the instrument.·to take the aspiration needle out of the tray, first pull out the handle section and hold it before taking the insertion section out of the tray.If the insertion section is taken out of the tray and held before the handle section is taken out, the insertion section may be deformed.·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.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• 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: 8844268
• MDR Text Key: 216687275
• Report Number: 8010047-2019-02759
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170388286
• UDI-Public: 04953170388286
• Combination Product (y/n): N
• PMA/PMN Number: K160098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4022
• Device Lot Number: FR844933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1