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	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: e1 (telephone number): (b)(6).H4 (device mfg date): 7/1/2024 - only the month and year are known, the day is merely a placeholder.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
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 two of three.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The subject device was not returned to olympus.Therefore, the reported phenomenon and condition of the device could not be confirmed.A definitive root cause could not be identified.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: 21678206
• Report Number: 9614641-2025-00361
• Device Sequence Number: 8349411
• 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
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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?: No
• 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: 03/24/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/17/2025
• Date Device Manufactured: 07/01/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown