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

Model Number NM-401L-0423

Device Problem Infusion or Flow Problem (2964)

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

Event Date 05/22/2023

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 any additional information is provided by the user facility.

Event Description

An olympus employee reported on behalf of a customer, the single use injector would only inject when withdrawn.The event occurred during a therapeutic flexible laryngoscopy with injection of botox.The procedure was completed using a re-usable flexible sheath with a maj-656 (disposable needle).There was some additional time added to the procedure due to opening the replacement devices.There was no report of medical intervention being required or patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and the device evaluation.Please see updates to d8, d9, h3, h4, h6 and h10.H4: based on the 3 digit lot number provided, the manufacturing date of the device was in the month of october 2022 but a specific date could not be identified.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The device was returned without the original packaging and there was no damage to the slider, handle, or injection port.The insertion tube was inspected by running two fingers down the entire length and it was observed that there was a pinch where the tube meets the handle.The distal end was observed under a microscope, foreign material was seen, indicating the device has been used.A functional check was performed which confirmed the needle smoothly extended and retracted as intended.The needle extends 4mm out of the insertion tube sheath, which is in specification according to the instruction manual.A syringe was attached to the injection port, however due to the pinch insertion tube, fluid was not able to be expelled from the distal end.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¿s likely that the event (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.Additionally, it's probable that 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.-the kink of the tube.-angle of the distal end of the endoscope however, a final root cause of this event was unable to be identified.The following is included in the instructions for use: ¿-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.

• 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: 17084232
• MDR Text Key: 317674244
• Report Number: 9614641-2023-00817
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422621
• UDI-Public: 04953170422621
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0423
• Device Lot Number: 2XV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• 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