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

Model Number NM-401L-0425

Device Problem No Flow (2991)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.

Event Description

It was reported that the single use injector was part of 5 needles which failed during various different procedures.The issue occurred during an unspecified procedure in which the needles were placed through the channeled endoscope and the endoscope was placed through the patient¿s nose to get to their throat.The only other device was the channeled olympus endoscope.There was a delay of approximately 5 minutes.The patient was awake during the exam.The intended procedure was completed with another similar device.A new needle from the box of 5 was used.Same lot number.There were no reports of patient or user harm associated with this event.Related patient identifiers: (b)(6).

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.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The device was evaluated and observed to have a white material around the distal end and throughout the sheath.Two fingers were ran down the entire length of the insertion tube portion sheath, no kinks or damages felt.The slider, injection port and handle are in good condition without any damage.A function check was performed by manipulating the slider back and forth.The needle extended 4mm then retracted as intended.A 5ml syringe was connected to the injection port, when the syringe was pressed down, the normal saline would not expel out of the distal end, verifying user¿s request.Based on the results of the investigation, it is likely that the event occurred due to compressive buckling on the needle tube, caused when the needle was extended because of the great friction between the outer tube and the needle.The friction between the outer tube and the needle increased by the following factors: ·the needle extended/retracted while the tube was coiled in inspection of operation.·the slider was abruptly pushed.·angle of the distal end of the endoscope however, the definitive root cause was unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: "¿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 field performance for this device.

Event Description

It was reported the needle was engaged, however, solution would not come out of tip.The device was being used for vocal cord injections.The customer kept trying different injection needles until they found one that worked.

• 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: 18637672
• MDR Text Key: 335311151
• Report Number: 9614641-2024-00253
• Device Sequence Number: 1
• Product Code: FBK
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2024
• 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: 37V
• 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: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• 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