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

Model Number NA-U401SX-4021

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that the event occurred due to the following occurrence mechanism.The needle tube buckled significantly due to bending force.It might have occurred due to the movement of the patient during the procedure.A load was applied to the bent needle tube in a direction to back to straight by pulling the needle slider.This caused the needle tube to break.The above device handling has warned in the instruction manual as follows.When inserting the instrument into the endoscope, the distal end of the needle tube may be bent.When piercing the target, confirm the distal end of the sheath and needle tube in the endoscopic field of view and/or ultrasound image while considering such bending.Otherwise, patient injury such as perforation, bleeding, or mucous membrane damage may occur.Do not try to straighten a bent or deformed needle with your hands because the needle may break.Use a spare needle instead.

Event Description

During an endobronchial ultrasound-guided procedure, the subject device was used.Since the needle of the first device couldn't extend, the user exchanged it for the subject device.When the user threaded the guidewire in the needle, the top part fell off.Ct showed the guidewire remained in the patient and the tip of the needle was broken and was sitting in the patient's lymph node.

Manufacturer Narrative

This is a supplemental report to provide additional information.It was informed by the customer that the broken and retained part was stylet wire.The patient underwent the surgery to remove the wire at another hospital, hence the difficulty in retrieving the fragment, and was discharged home on the same day with no further incident.The user requested a description of the removed wire, but the surgeon who removed the wire at another hospital didn't confirm.The local representative of olympus analyzed the event based on the information from the customer, and reported the analyzed result to olympus medical systems corp.(omsc).*the subject device was used as the first device.The broken and remained in the patient part was needle, not stylet wire.Because the stylet wire is deliberately designed to be blunt, whereas the needle itself is sharp.It¿s very unlikely that the stylet wire could have punctured through and entered tissues.*the user was unable to extend the needle from the sheath, because it was not physically present, having remained inside the patient.There was the second device but it was not used because the stylet knob became detached during pre-inspection.Although the actual defect device was not sent, there is no similar defect report and it is possible to infer the cause from the investigation results of similar cases in the past, so it is unnecessary to investigate using the same structure of equipment and similar equipment.Based on the additional information and past similar cases, omsc presumes that the event occurred due to the following occurrence mechanism.1.A bending force was applied to the needle tube when a needle tube was pierced into a hard tissue.This caused the needle tube to bend excessively.2.A force was applied to the bent needle when the needle slider was pulled, and it straightened the needle tube.As a result, the needle tube broke.3.The broken needle remained in the patient¿s body.

• 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: 11276969
• MDR Text Key: 233319041
• Report Number: 8010047-2021-02215
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170388248
• UDI-Public: 04953170388248
• Combination Product (y/n): N
• PMA/PMN Number: K160098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4021
• Device Lot Number: FR912790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other