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

Model Number NM-610U-0423

Device Problem Failure to Infuse (2340)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the outer tube was buckled.The needle tube presented compressive buckling.The needle could not extend from the outer tube and it was not possible to inject liquid when the slider was pushed.However, it was possible to inject liquid when the slider was pulled.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that when the single use injector needle was pushed out, the lock on the hand side did not click into place.After that, when the clinician passed it through an endoscope and tried to get the fluid and needle out, the clinician could not send the fluid, and the needle did not come out either.The issue was found during an unspecified therapeutic procedure, which was completed with another similar device.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to d4 for information inadvertently left out of previous report.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, it is likely liquid could not be injected due to buckling of the needle tube.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.Since friction resistance between the outer tube and needle tube has increased, compressive buckling might have occurred when the needle was extended.A likely mechanism causing friction resistance between outer tube and needle tube might be the following: - the tube was coiled during the inspection for operation - the slider was pushed abruptly.- the kink of the tube.A definitive root cause cannot be identified.The event can be detected and prevented by following the instructions for use 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.·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
• 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: 18070236
• MDR Text Key: 327372123
• Report Number: 9614641-2023-01656
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422836
• UDI-Public: 04953170422836
• 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: 11/28/2023

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-0423
• Device Lot Number: 34V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/04/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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