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 Foreign Body In Patient (2687)

Event Date 04/21/2022

Event Type  Injury  

Event Description

The customer reported to olympus, during a bronchoscopy, the subject device fractured in the patient's airway when sampling a station 11r lymph node.The device fragment was 2cm long and successfully retrieved from the patient using olympus endojaw alligator model fb-211d forceps.There was a two (2) minute procedural delay when the device broke and retrieved while the patient was under moderate sedation.The intended procedure was cancelled.A post-operative chest x-ray confirmed no retained fragments and no pneumothorax.The patient was asymptomatic post-operatively.The subject device was not inspected prior to use.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Weight 173.8 pounds.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2951238-2022-00407.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to excessive force based on previous complaints.Content of the instruction manual (drawing number: rk1001, revision number :4) was confirmed.The instruction manual contains the following descriptions, and it warns against this event.·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.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide the manufacturing date.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14462710
• MDR Text Key: 294780721
• Report Number: 8010047-2022-08654
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170388248
• UDI-Public: 04953170388248
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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: KR208513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BF-UC190F, SERIAL (B)(6); BF1-TH190, SERIAL (B)(6)
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: White