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

Model Number NM-401L-0425

Device Problem Failure to Deliver (2338)

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

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation and follow up with the user facility is currently being performed.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

An olympus representative reported to olympus on behalf of the customer that when single use injector, the needle was engaged, and the solution would not come out of the syringe during the therapeutic laryngeal injection procedure.The intended procedure was performed with another similar device.There was no delay nor patient harm or impact associated with the reported event.

Event Description

This report is linked to patient identifier: (b)(6).

Manufacturer Narrative

Additional information has been received from the customer.This supplemental report is being submitted to provide this information.Please see the updates in sections: the device was returned to olympus for evaluation and a visual inspection on the device found; the handle, slider and locking mechanism are all in working condition.The insertion tube portion sheath had a major kink observed where the sheath meets the handle.During the functional testing, the needle extended and retracted as intended.A 5ml syringe was connected to the injection port, when the syringe was press down, the normal saline would not expel out of the distal end, however it came out from the kink in the sheath, which confirmed the customer¿s reported allegation.Based on the results of the investigation, it is likely that the following led to the malfunction: it was likely that the phenomenon ¿unable to inject liquid into the target tissue¿ occurred due to the compressive bucking on the needle tube.The compressive buckling on the needle tube was likely caused when the needle was extended because of the friction between the outer tube and the needle.This might have caused the tube to buckle.However, a definitive root cause cannot be identified.A device history review revealed no issues that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu): before use, prepare and inspect the instrument as instructed below.Should the any irregularity be observed, do not use the instrument; use a spare 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.·straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.¿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 abnormalities such as significant deformations or excessive bends are found, do not use the instrument.Otherwise, it may cause perforation, bleeding, mucous membrane damage.¿confirm that the needle extends in the endoscopic image are normal.If any abnormalities are found, do not use the instrument.Otherwise, it may cause perforation, bleeding or mucous membrane damage.¿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.¿do not push the slider abruptly, otherwise the needle will be rapidly extended from the distal end of the tube.This could result in patient injury, such as perforation, bleeding or mucous membrane damage.It could also damage the instrument.Olympus will continue to monitor the field performance of this device.

• Brand Name: SINGLE USE INJECTOR
• 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: 17581868
• MDR Text Key: 321520190
• Report Number: 9614641-2023-01195
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422638
• UDI-Public: 04953170422638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0425
• Device Lot Number: 27V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1