MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE

Model Number	NA-U401SX-4025N
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus that during an unspecified endoscopic procedure, where the patient¿s esophagus was to blocked and injected with steroids as an additional treatment, the sleeve of the needle had lost contact with the end of the aspiration needle while inside the lymph node.The needle was not able to be withdrawn without removing the entire needle holder, therefore, the needle was cut at the and the needle and the scope were then withdrawn simultaneously.The procedure was aborted intraoperatively.This complaint required two reports.The related patient identifiers are as follows: (b)(6): na-u401-sx4025n.(b)(6): bf-uc190f.This medwatch report is for patient identifier: (b)(6).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: b1, d9, h1, h4, h6 and h10.Upon evaluation of the returned device, it was found that the insertion part had been cut with a tool, and it was sent with the needle sticking out.Since it was severed, the needle could not be retracted.As the needle tube had been severed, it was not possible to confirm that liquids could be delivered.When the products were disassembled, the needle tube was able to be removed from the adhesive part between the suction port and needle tube.The adhesive between the two was appropriate.The device history record was reviewed, and found no abnormalities.The instructions for use discussed the following related to this event: -do not round the insertion part smaller than 15 cm in diameter.The aspiration biopsy needle may break.-do not insert the aspiration biopsy needle while the endoscope is angled.Damage to the endoscope or aspiration biopsy needle may result.-do not forcefully insert the aspiration biopsy needle into the endoscope.It may suddenly protrude from the tip of the endoscope, resulting in perforation, major bleeding, mucous membrane damage, or damage to the endoscope or aspiration biopsy needle.Also, if the resistance is high and insertion is difficult, return the angle of the endoscope until it can be inserted without difficulty.The reason for the delay in the procedure is presumed to be that the needle tube came off the suction port.Based on the result of checking the actual product, we believe that the cause of the detachment of the needle tube occurred due to the following mechanism: due to the severe angle of the endoscope, the sliding resistance of the needle tube increased and the operation became heavy.The needle slider was pulled strongly to pull in the needle tube, and the needle tube fixing part of the suction port was damaged beyond its resistance.Additional force was added, and the needle tube came off.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: ASPIRATION NEEDLE
• 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: 16329103
• Report Number: 9614641-2023-00185
• Device Sequence Number: 18346250
• Product Code: KTI
• UDI-Device Identifier: 04953170402005
• UDI-Public: 04953170402005
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K190239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NA-U401SX-4025N
• Device Lot Number: 2YK
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EVIS EUS ULTRASOUND BRONCHOVIDEO SCOPE-BF-UC190F
• Patient Sex: Unknown