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

Model Number NM-610U-0326

Device Problem Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the single-use injector became difficult to pump the fluid.The issue was found during a therapeutic endoscopic submucosal dissection procedure.The procedure was completed with a similar device.There were no reports of patient or user harm.

Manufacturer Narrative

The device was returned to olympus for evaluation, and the customer¿s allegation was not confirmed.In addition, the evaluation found the following: the outer tube was not buckled, and the needle tube was not buckling.No other abnormalities that could lead to the phenomenon of the reported event could not be confirmed.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.

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, the likely cause of the event is due to tissue or other objects temporarily clogging the needle.However, the root cause of the reported event is unable to be determined.The event can be detected and prevented by following the instructions for use (ifu) which state: ·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.Before use, be sure to perform the preparations and inspections listed below.If any abnormality is suspected, do not use the needle and use a spare needle.If you use this product that is suspected of having an abnormality, it may not only not function properly, but may also lead to infection, tissue inflammation, perforation, major bleeding, mucous membrane damage, or damage to the device or reduced functionality.·do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.Do not roll the insertion tube smaller than 15cm in diameter.Doing so may cause damage to the insertion tube.·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.Before use, check that there are no abnormalities such as crushing or bending of the insertion tube.This may lead to tissue inflammation, perforation, major bleeding, mucous membrane damage, or damage to the endoscope.Before use, check that the needle and needle connection part are free from bends or other abnormalities.This may lead to perforation, major bleeding, mucosal damage, etc.·straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.Do not check operation with the tube rolled up.Doing so may bend the tube inside the control unit and cause the product to malfunction.·operate the slider slowly, otherwise the tube could buckle.Operate the slider slowly.If you operate it suddenly, the tube inside the operation unit may bend and the product may not function properly.·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.Insert this product slowly.If you insert it too forcefully, it may suddenly protrude from the tip of the endoscope, which may lead to perforation, major bleeding, mucous membrane damage, or damage to the endoscope or this product.·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.Do not insert this product into the forceps plug of the endoscope at an angle, or hold the part away from the forceps plug.The insertion tube may 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.If the insertion tube bends during use, discontinue use of the product.There is a risk that the functionality of this product may not be ensured, such as not being able to stick out the needle or injecting the drug.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE INJECTOR NM600/610
• Type of Device: 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: 18253688
• MDR Text Key: 329710152
• Report Number: 9614641-2023-01833
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422805
• UDI-Public: 04953170422805
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

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
• Device Operator: Health Professional
• Device Model Number: NM-610U-0326
• Device Lot Number: 35V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/03/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PCF-H290T S/N: UNKNOWN