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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that part of the plastic sheathing of the subject device came off.The part came off outside of the patient.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The suspect device was sent to olympus for evaluation.Inspection and testing is in progress.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and the device evaluation.B3/b5: no additional information has been provided.The device evaluation found there was a bend near the tip of the insertion part.There were no scrapes on the exterior of the sheath.No dropped items were sent with the subject device.A foreign body was adhered to the tip of the needle.H4: the subject device was manufactured in april 2021.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation results, the foreign object attached to the needle tip is likely tissue that adhered when it was punctured.It is also likely that the needle tube may have bent during endoscopic insertion or when puncturing the tissue.The specific root cause of the plastic sheathing coming off the subject device could not be determined at this time.Correction: per the legal manufacturer, there is no potential for this issue of the plastic sheathing of the subject device to come off to cause or contribute to death or serious injury if the malfunction were to recur.The following information is stated in the instructions for use (ifu): "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.".

• 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: 15739451
• Report Number: 9614641-2022-00571
• Device Sequence Number: 2917809
• Product Code: FCG
• UDI-Device Identifier: 04953170402586
• UDI-Public: 04953170402586
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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
• Operator of Device: Health Professional
• Device Model Number: NA-U201H-8022
• Device Lot Number: 14K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown