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

Model Number	NA-201SX-4021
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative, on behalf of a user facility, reported that during a diagnostic endobronchial ultrasound procedure using the evis eus ultrasound bronchofibervideoscope with a single use aspiration needle, there was resistance.It was initially stated there was a hole on the insertion channel.Additional information was obtained to clarify the event.Upon the first pass with the first needle, the physician met resistance, so the pass was stopped.The needle was taken out of the scope, and it was noticed that the end of the catheter was broken off and the metal tip was sticking out.The needle was placed aside.A second needle was used, and another pass was tried.Resistance was felt again, so the needle was pulled out.The scope was removed, and the physician tried to put the catheter down the scope outside of the patient and could not advance the needle to the end of the scope.A second scope was used with another (third) needle to finish the procedure, and it was not cancelled.Due to the product issues, the procedure was prolonged by about 30-40 minutes.It was reported that the scope was plugged into the tower, and there were no error messages associated with this event.The patient's condition was not affected by this, and no interventions were required.Patient identifier (b)(6) is for the evis eus ultrasound bronchofibervideoscope.Patient identifier (b)(6) is for the single use aspiration needle.Patient identifier (b)(6) is for the single use aspiration needle.
Additional Manufacturer Narrative
This report was submitted by the importer under the importer's report number: 2429304-2023-00115 the device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional 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.Based on the results of the investigation, it was determined that the prolonged procedure was due to breakage of the device sheath tip.However, since the actual device was not returned for an evaluation, the defect could not be confirmed.Therefore, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not apply excessive bending, pulling or pressure to this product.It may lead to equipment damage or functional deterioration.Do not round the insertion tube 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.Return the endoscope's up/down angle lever to neutral before inserting the aspiration needle into the endoscope.Insertion with the angle fixed may damage the endoscope or aspiration needle.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: SINGLE USE 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: 16950893
• Report Number: 9614641-2023-00685
• Device Sequence Number: 7041275
• Product Code: FCG
• UDI-Device Identifier: 04953170240935
• UDI-Public: 04953170240935
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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-201SX-4021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE¿ SN(B)(6).; SINGLE USE ASPIRATION NEEDLE ¿ LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown