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

Model Number NA-201SX-4021

Device Problems Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)

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

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

This report was submitted by the importer under the importer's report number: (b)(4).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.

Event 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.

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
• Type of Device: 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: 16950897
• MDR Text Key: 315439432
• Report Number: 9614641-2023-00686
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170240935
• UDI-Public: 04953170240935
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EVIS ULTRASOUND BRONCHOFIBERVIDEOSCOPE-SN (B)(6).; SINGLE USE ASPIRATION NEEDLE ¿ LOT UNKNOWN.
• Patient Outcome(s): Other