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

Model Number	NM-610U-0326
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported two single use injectors (nm-610u-0326) could not deliver fluid.The device was not inspected before use.The procedure was a therapeutic large intestine electrostatic discharge, which was completed using another of the same device.There were no reports of patient harm.
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.It has been over 8 months since the subject device was manufactured.Based on the results of the investigation, the cause for the event can be inferred that friction resistance has increased between the outer tube and the needle tube due to buckling of the tube causing the unable to extend needle.A bending force might have been applied to the tube when the device was inserted into the endoscope, removed from the sterile package or during pre-inspection.This might have caused the tube to buckle.However, the root cause of the problem could not be conclusively identified.The following is included in the instructions for use (ifu): the instruction manual contains the following descriptions, and it warns against this event.(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.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: 19568544
• Report Number: 9614641-2024-01289
• Device Sequence Number: 12499810
• Product Code: FBK
• UDI-Device Identifier: 04953170422805
• UDI-Public: 04953170422805
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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-0326
• Device Lot Number: 3YV
• Was Device Available for Evaluation?: Yes
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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