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

Model Number	NM-610U-0325
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6) hospital (added here due to maximum character limitation).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that when opening a new product of single use injector nm600/610 for use.The customer tried to flush it with the syringe, but there was considerable resistance to the syringe.The syringe was replaced, and the therapeutic procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, it is likely the malfunction occurred because a fibrous foreign body that appeared to be gauze was lodged inside of the needle section.The causes of the clogging might be likely due to the following mechanism: 1) part of the gauze used at the procedure adhered to the syringe tip and the injection port.2) part of the gauze was contaminated in the tube.3) the needle lumen was clogged by gauze.The instructions for use warns the prevention method associated with the event in (rk1746 rev02).·before use, prepare and inspect the instrument as instructed below.Should any irregularity be observed, do not use the instrument; use a spare the instead.Damage or irregularity may compromise patient or user safety; for example, posing an infection control risk, causing tissue irritation, perforation, bleeding, or mucous membrane damage, and may result in more severe equipment damage.·do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.·before use, confirm that the needle and the insertion portion are not damaged.If any irregularity such as significant deformations or excessive bends is found, do not use the instrument.Otherwise, it may cause perforation, bleeding, mucous membrane damage.·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.·do not advance or extend the instrument abruptly.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.·when inserting the instrument into the endoscope, retract the needle into the tube, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.·stop using the instrument if the insertion portion bends excessively during use.This could result in malfunction, such as failing to extend the needle or inject a fluid.·be sure to use a fluid intended for patient use when inspecting the injection.If other fluids are used, the fluids may remain in the instrument.This could pose an infection control risk or cause tissue irritation.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19003366
• Report Number: 9614641-2024-00788
• Device Sequence Number: 9383863
• Product Code: FBK
• UDI-Device Identifier: 04953170422799
• UDI-Public: 04953170422799
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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-0325
• Device Lot Number: 3XY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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