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

Model Number	NM-401L-0423
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reports are being submitted on both single use injectors used during the procedure.Please refer to the following reports: patient identifier of (b)(6) is related to model number: nm-401l-0423, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: nm-401l-0423, serial number: (b)(4).During device evaluation at olympus, it was found the complaint was confirmed and the tube sheath was kinked.In addition, evaluation found the needle was able to be retracted (able to inject) and the needle was able to be extended (unable to inject).This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
The customer reported that a therapeutic gastric ulcer bleeding case was being done.Prior to the procedure, two injectors were opened and inspected by the nurse.No issues were found when the injectors were tested.During the procedure, when the injector, with the needle out, was inside the scope, the nurse injected the adrenaline solution; however, the solution was unable to flow.The solution was stuck and could not flow through the lumen despite multiple attempts.The nurse tried to examine and test the injector after taking it out of the scope, but the same issue occurred.The procedure was completed using another injector.There was no reported patient harm or impact due to this event.
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, it was likely that the phenomenon occurred due to the compressive bucking on the needle tube in the handle.The compressive buckling on the needle tube was likely caused when the needle was extended because of the great friction between the outer tube and the needle.It was likely that the friction between the outer tube and the needle increased by the following factors.The needle extended/retracted while the tube was coiled in inspection of operation.The slider was abruptly pushed.Angle of the distal end of the endoscope.Kink of the tube.However, the root cause of the reported event could not be identified.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: 16276559
• Report Number: 9614641-2023-00146
• Device Sequence Number: 6645941
• Product Code: FBK
• UDI-Device Identifier: 04953170422621
• UDI-Public: 04953170422621
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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-0423
• Device Lot Number: K2120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2023
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown