MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U201H

Model Number	NA-U201H-8022
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports during an unspecified procedure using a single use aspiration needle, the needle broke off inside the patient (inside the tumor).It is unknown if the needle was successfully retrieved.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.
Additional Manufacturer Narrative
The subject device was manufactured on february, 2022 based on the provided 3 digit lot information.This event has been reported by the importer on mdr# 2429304 - 2022 - 00018.The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on facility medwatch received.New information was added to the following fields: b5, e1, e2, e3, e4, g2.
Event or Problem Description
Additional information was reported by facility pertaining to this event: single-use aspiration needle broke off in mass in pancreatic head during fine needle biopsy.
Additional 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 record (dhr) review.New information was added to the following fields: h6, h10.The dhr for this device was reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The device was not returned to olympus for evaluation.Images were provided which revealed the sheath was pulled out of the actuator.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 the following mechanism: ·the needle tube buckled under bending load during endoscopic insertion/detachment or puncture.·a load was applied to the buckled needle tube in the direction of straightening it back to a straight line.·the needle tube was bent and stretched, which reduced its strength and caused it to fracture.It is also possible that the sheath came off the handle due to some tensile load being applied to the product sheath during handling.The instructions for use (ifu) states the following: ·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 bent or break.·if you feel excessive resistance while operating the instrument, do not push the needle slider forcibly.Reduce the angulation of the endoscope until the instrument passes smoothly.Advance the sheath slowly until the distal end of the sheath appears within the endoscopic or ultrasonic field of view.If excessive resistance is encountered after reducing the angulation of the endoscope entirely, do not use the instrument.Forcing the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.Olympus will continue to monitor the field performance of the device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U201H
• Common Device Name: ASPIRATION NEEDLE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15198996
• Report Number: 9614641-2022-00129
• Device Sequence Number: 6337813
• Product Code: FCG
• UDI-Device Identifier: 04953170402586
• UDI-Public: 04953170402586
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K181994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NA-U201H-8022
• Device Lot Number: 22K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 09/16/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/14/2022; 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown