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 Needle Stick/Puncture (2462)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.A potential cause is failure to follow instructions for use.It was reported that during the procedure the needle was seen bent but was used anyway prior to the breakage.The needle instruction manual has warnings that address bent needles: ¿do not use an aspiration needle that has an irregularly bent or deformed needle tube.Otherwise, unexpected perforation, bleeding, or mucous membrane damage may occur.¿when inserting the instrument, 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.Do not try to straighten a bent or deformed needle with your hands because the needle may break.Use a spare needle instead.¿as a preventive measure, the instruction manual for the device has directions for pre-procedure visual and functional inspection, including explicit instructions to look for deformation at the distal end.The instruction manual also advises, "always have a spare instrument available in case the primary instrument malfunctions.¿.

Event Description

Olympus was informed that during an endobronchial ultrasound bronchoscopy (ebus) procedure, while performing the needle biopsy of the lymph node (station4r) the needle broke in half inside the patient.The broken needle was sticking out from the patient¿s tracheal wall and the doctor removed it with forceps.It was reported that there were two successful passes of the biopsy needle with no insertion issues and then broke during the third pass.There was no tissue trauma from the retrieval of the needle.The doctor withdrew the needle through the inside of the scope and then withdrew the scope.There was no additional medical or surgical intervention needed for the patient as a result of the event.The patient was in a stable condition and discharged home the same day.Additionally, the user facility reported that there was no damage to the scope.The needle and other equipment used were inspected prior to use and no anomalies were found.

Manufacturer Narrative

This supplemental report is being submitted to correct section g3.

• 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: 8410586
• MDR Text Key: 141330031
• Report Number: 2951238-2019-00530
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

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-4021
• Device Lot Number: PW305218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR