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

Model Number	NM-401L-0623
Medical Device Problem Codes	Failure to Prime (1492); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.Related complaint: (b)(4).
Event or Problem Description
It was reported, the injector and sheath set was unable to inject kenakort via the nasal device after bougienage using a scleral needle.The needle was deflated outside the body with the needle retracted and then handed to the doctor.When an attempt was made inside the body to inject the kenakort with an open needle, this could not be done as there was a great deal of resistance and nothing could be injected.The needle was changed and the same problem occurred with the second needle.Both needles were also tried outside the body.Injection worked with the needle retracted, but not with the needle extended.There was a major time delay and the whole device had to be changed and then a normal sclerosing needle had to be taken.There was no reported injury or harm to the patient.There is no indication that the delay was over 30 minutes or that the patient was under general anesthesia.The issue occurred during a therapeutic nasal kenakort injection.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The needle tube was buckled.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 reported issue occurred due to a buckled needle tube.A definitive cause was not established however the following may have contributed to the reported issue: the needle extended/retracted while the tube was coiled in inspection of operation.The slider was abruptly pushed.A kink in the tube or incorrect angle of the distal end of the endoscope.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) section(s) below: "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
• Common Device Name: 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: 19634148
• Report Number: 9614641-2024-01352
• Device Sequence Number: 7137639
• Product Code: FBK
• UDI-Device Identifier: 04953170422669
• UDI-Public: 04953170422669
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: NM-401L-0623
• Device Lot Number: 22V3046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown