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

Model Number	NA-201SX-4022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received however; the estimation has not been completed as of date.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 the single use aspiration needle was damaged after it was removed from the scope.The event occurred during a diagnostic endobronchial ultrasound operation.A similar device was used to complete the operation and there was no patient harm or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation and device evaluation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The insertion buckled at approximately 10 mm from the tip.Tip of the insertion part was checked, the coil sheath was deformed and a hole was found in the sheath.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 a definitive root cause was not established.However, multiple factors may have contributed to the pierced sheath.Distal end of the sheath was pressed against tissues of the trachea, bronchi, esophagus and surrounding organs.Scope was forcefully pushed into the patient¿s body while the sheath was pressed against the tissue causing the sheath to bend.When an attempt was made to extend the needle while the sheath was bent, the tip of the needle to be caught in the bent area of the sheath.As a result, the needle could not be extended.Needle protruded from the side surface of the sheath when an attempt was made to extend the needle by forcefully applying a force to the operating portion while the needle could not be extended.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿·take the instrument out of the tray by holding the sheath not to make the sheath pop out of the tray.Otherwise, the insertion portion of the instrument might be broken.Also, if the insertion portion pops out of the tray by elasticity, doctors or patients might be injured by the distal end of needle tube, sheath, and stylet.·do not insert this instrument when the endoscope is angulated.This could damage the endoscope and/or this instrument.·turn the up/down angulation control lever to the neutral position to straighten the endoscope before the insertion of this instrument into the endoscope.Otherwise, this could damage the endoscope and/or this instrument.·if you feel excessive resistance while operating the needle, do not push the needle slider forcibly.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the instrument and/or endoscope.·do not round the insertion tube smaller than 15 cm in diameter.The aspiration biopsy needle may break.¿ 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: 17153881
• Report Number: 9614641-2023-00863
• Device Sequence Number: 3929625
• Product Code: FCG
• UDI-Device Identifier: 04953170389900
• UDI-Public: 04953170389900
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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: NA-201SX-4022
• Device Lot Number: V2Z17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2022
• 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