MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number	NM-401L-0425
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has been returned to olympus for evaluation.Visual inspection was performed on the device and found no abnormality on the tubing appearance.Observed no kinks inside the needle tube, and no crack around the injection port.The slider could extend or retract the needle smoothly.Further checking, when using a test syringe to inject water into the injection port, confirmed that fluid was able to expel out when the needle was in the sheath, but when the needle was out of the sheath, the fluid would not flow.No water leak was that from the tube sheath during water injection.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.Product return receipt date is not available currently.
Event or Problem Description
The olympus territory manager reported (on behalf of the customer) that while using the single use injector, fluid was not dispensing through the syringe into the patient as intended.The issue occurred during the therapeutic procedure, and the procedure was completed with a similar device.There was no procedural delay or additional devices associated with the event.There was no patient harm associated with the event.This report is part of three related events.(patient identifiers: (b)(6) and (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the inner needle tubing of the device appeared to be buckled inside of the handle.However, the definitive root cause of the needle issue could not be determined.It is possible that the compressive bucking occurred due to increased friction resistance between the outer tube and the needle tube when the needle was extended.Friction resistance between the outer tube and the needle tube may have been caused by the tube being coiled during the inspection for operation, or the slider being pushed abruptly.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.Operate the slider slowly, otherwise the tube could buckle.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE INJECTOR
• Common Device Name: INJECTOR AND SHEATHSET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16225476
• Report Number: 9614641-2023-00103
• Device Sequence Number: 17455409
• Product Code: FBK
• UDI-Device Identifier: 04953170382345
• UDI-Public: 04953170382345
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K902736
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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: NM-401L-0425
• Device Lot Number: 29V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown