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

Model Number	NA-201SX-4022
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device was not returned to olympus for evaluation, a root cause for the reported event cannot be determined.If additional information becomes available or the device is returned for evaluation, a supplemental report will be submitted.
Event or Problem Description
Olympus was informed that during an endobronchial ultrasound procedure, the level 4r node was challenging to access and on inspection of the needle it was felt to be dull.It was assumed to be due to hard cartilaginous tissue at the biopsy site, so a new needle was used and the case concluded without issue.In the pacu, the patient coughed up the tip of the needle and it was discovered by the pacu nurse.A chest x-ray was ordered to verify there was no metallic object left behind.There was no patient injury or harm, associated with the problem, reported to olympus.
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation.Since the device lot number and date of manufacture are unknown, a device history record (dhr) review for the subject product was performed on production records, created between (b)(6) 2020 and (b)(6) 2021.No abnormalities were identified which could have caused or contributed to the reported problem.The legal manufacturer performed an investigation.A definitive root cause for the reported problem could not be identified since the device was not returned for evaluation.Based on the investigation results of similar reported complaints, the reported problem occurred likely due to the following mechanism: the needle buckled significantly due to a bending force, possibly due to a movement of the patient during the procedure.A load was applied to the bent needle tube by pulling the needle slider and the resulting force caused the needle tube to bend severely.As stated in the instructions for use, as a preventive measure, "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 or Problem Description
After the procedure it was noticed that the needle was fractured.The procedure being performed was a diagnostic bronchoscopy.There were no other devices involved in the event.It is unknown whether there was any delay in the procedure.The intended procedure was completed.The same device was not used to complete the procedure.The device failed in the middle of the procedure.There was no bleeding.The patient is currently stable.The needle was fractured when biopsies of the level 4r node were being performed.The issue may have been in contact with a cartilaginous ring during the needle pass however, nothing out of the ordinary was being done and the approach was very standard.Per the user facility, this is the first time they have experienced the problem.There was no obvious issue with the needle prior to use.The follow up x-ray did not show any retained material.The needle had likely performed approximately six passes of other sites prior to the issue.No medical intervention was needed after the patient coughed up the needle tip.
Additional Manufacturer Narrative
This supplemental report is submitted to provide additional event related information.Update to section b5.

• 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: 11289941
• Report Number: 8010047-2021-02297
• Device Sequence Number: 3843094
• Product Code: FCG
• UDI-Device Identifier: 04953170180972
• UDI-Public: 04953170180972
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2021

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NA-201SX-4022
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/11/2021; 03/17/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/24/2021; 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No