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

Model Number	NA-201SX-4022
Medical Device Problem Codes	Material Perforation (2205); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to olympus, that the single use aspiration needle encountered resistance when it was inserted for an endobronchial ultrasound guided biopsy and the needle was withdrawn from the sheath.The needle was removed from the device and rechecked.The procedure was attempted again and the needle was again waved from the sheath.The needle sheath was found to be punctured laterally about 0.5 cm from the end.The needle pierced the sheath on the side which was visible.The biopsy was for the evaluation of nodal lesions (hilar lymphadenopathy) and it was completed with a similar device.The device was connected to a leak tested and the leak test showed that the ultrasound bronchofiberoscope was damaged and leaking from the biopsy channel.There were no reports of patient harm associated with the event.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Sections h3, h4, h6, and h10 were updated.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 needle penetrated the sheath.The insertion part was buckled at a position about 10 mm from the tip.The coil sheath was deformed and there was a hole in the outer tube.However, the definitive root cause of the damage could not be determined.Iis possible that the distal end of the needle tube got caught in the coil when extended from the sheath, buckling near the hard part and insertion part caused bending due to bending load applied to the needle tube when it was removed from the tray or inspected before use, the distal end of the sheath was pressed against tissues of the trachea, bronchi, esophagus and surrounding organs, the scope was forcefully pushed into the patient¿s body while the sheath was pressed against the tissue causing the sheath to bend, the needle was extended while the sheath was bent, or the 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 instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿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: 17373557
• Report Number: 9614641-2023-01016
• Device Sequence Number: 20592193
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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: 2XV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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: MODEL NUMBER: BF UC 190F, SERIAL NUMBER: (B)(6).
• Patient Sex: Unknown