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

Model Number NA-201SX-4021

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

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

Event Date 07/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.As a precaution, the device instruction manual recommends, ¿always have a spare instrument available in case the primary instrument malfunctions.¿ pre-procedure inspection instructions in the manual also state, ¿make sure that the adapter biopsy valve, the needle adjuster, the stopper, the connector section and the connecting-slider are not damaged.¿ the pre-procedure inspection also includes operational verification of the needle adjuster and resulting needle extension length.The instruction manual also states that during the procedure, ¿confirm that the needle slider is pulled until it clicks and is locked by the needle adjuster before inserting the instrument into the endoscope.Otherwise, the needle¿s distal end may pierce the endoscope¿s instrument channel or the needle¿s distal end may extend from the distal end of the endoscope abruptly.This could cause patient injury¿.Before insertion, ¿confirm that the needle adjuster is in the proximal position and that the needle adjuster lever is securely tightened.¿ and before taking a sample, ¿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.¿.

Event Description

Olympus was informed that during an ebus procedure, the needle adjuster malfunctioned and the needle went into tissue 1 mm deeper than intended.There was no reported patient injury, additional bleeding, or device fragment fallen into the patient.There had been no reported difficulties operating the device or inserting it into the endoscope beforehand.The needle was removed from the patient by withdrawal through the endoscope.The intended procedure was completed.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.The proximal portion of the device was returned to olympus for evaluation; the insertion portion, needle and stylet wire were missing and not returned.The evaluation did not duplicate the complaint for failed locking mechanism.Both the needle adjuster lever and needle adjuster knob were locking and unlocking properly.

• 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
• MDR Report Key: 7775010
• MDR Text Key: 117130864
• Report Number: 2951238-2018-00462
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170389887
• UDI-Public: 04953170389887
• Combination Product (y/n): N
• PMA/PMN Number: K050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• 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 Catalogue Number: NA-201SX-4021
• Device Lot Number: 83V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MODEL ENDOSCOPE