MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR NM600/610; INJECTOR AND SHEATHSET

Model Number	NM-610U-0523
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a therapeutic polypectomy procedure, the surgeon experienced "difficulty with the needle inserting into the bowel wall.They have had to have multiple tries to get the needle to enter the mucosal so that the injectate could be inserted - twice to use everlift to raise the polyp and once for the tattoo to mark a bowel cancer." there has been no report of adverse event/ harm associated with this event.This procedure was completed with a device of an unknown device of a different make/model.This is event one of three.
Additional Manufacturer Narrative
Additional information: e1 (telephone number): (b)(6).H4(manufacturing date of device) - only month and year is known, 01 was chosen as default.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Correction the manufacturing date h4: 7/10/2024 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, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide an updated device evaluation to a previously submitted report.The subject device was not returned; however, the user returned unused devices from the same lot and visual and functional inspections were performed.A definitive root cause could not be identified.The distal end of the needle of the unopened package was inspected, and no abnormalities were found.Additionally, the tube and slider were also inspected, and no abnormalities were observed.The needle puncture force was found to be within the acceptable range defined by the criteria.Therefore, the issue related to poor puncturability could not be replicated/confirmed.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: SINGLE USE INJECTOR NM600/610
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21677851
• Report Number: 9614641-2025-00359
• Device Sequence Number: 18077574
• Product Code: FBK
• UDI-Device Identifier: 04953170377976
• UDI-Public: 04953170377976
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K153625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2025

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-610U-0523
• Device Lot Number: 4K812847K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 04/03/2025; 07/14/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/30/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown