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

Model Number	NA-201SX-4022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user's reported weight is (b)(6) pounds.The device was not returned to olympus for evaluation.As reported, the event occurred a result of the needle not being retracted into the sheath.It was noted the cause of this is unknown.
Event or Problem Description
It was reported that excess force was required to deploy the needle during a lymphadenopathy.The procedure was completed planned.Following the procedure, the user experienced a needle stick as the needle was not retracted into the sheath when it was given to her.It was noted the cause of this is unknown.As a result of the needle puncture, a report was filed in house, the user received a tetanus shot and was tested for hepatitis and hiv along with the patient.They both tested negative.The user is in stable condition.
Additional Manufacturer Narrative
Corrected data: g4- aware date should be on (b)(6) 2020 as this event became reportable with notification that the user received a tetanus shot.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information (h6, h10) regarding the reported event.The definitive root cause could not be established.Based on the similar issue reported in the past, the probable cause has been determined as resistance increased between the needle tube and the tube which caused the inability of the needle to protrude from the sheath.Per the product instructions for use (ifu): "take the instrument out of the tray by holding the sheath not to make the sheath pop out of the tray.Otherwise, the insertion portion of the instrument might be broken.Also, if the insertion portion pops out of the tray by elasticity, doctors or patients might be injured by the distal end of needle tube, sheath, and stylet.Do not coil the insertion portion with a diameter of less than 150 mm.Doing so could damage the instrument." device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: 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: 10101618
• Report Number: 8010047-2020-02980
• Device Sequence Number: 11419394
• Product Code: FCG
• UDI-Device Identifier: 04953170180972
• UDI-Public: 04953170180972
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NA-201SX-4022
• Device Lot Number: 99V
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 05/22/2020; 09/18/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 06/10/2020; 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 70