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

Model Number	NA-401D-1321
Medical Device Problem Codes	Mechanical Problem (1384); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the reported issue is unknown at this time.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
Olympus received a medwatch report from the user facility reported that the "needle bent and broke through the sheath".According to the report, needle was being used to obtain endobronchial biopsy, the user pushed the needle out from the needle sheath as designed.However, as the needle was being pushed out of the sheath it bent and came out of sheath to the side instead of the needle coming out of the sheath straight.The needle tore the sheath.Did not puncture the internal working channel of bronchoscope.No harm to the patient since the needle and sheath had not come in contact with the patient's airway due to the bronchoscope position at the time of the incident.The device was replaced and the intended procedure (diagnostic bronchoscopy with endobronchial ultrasound) was completed using a smaller size biopsy needle.The procedure duration prolonged about ten (10) minutes while the respiratory therapist removed and obtained a different biopsy needle.Patient was not under anesthesia at the time of the incident.Provider checked for any bleeding or airway damage and did not find any.No harm was reported.No patient harm, no user injury reported as the result of the event.
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, and because the device was not returned for evaluation, the definitive root cause of the sheath damage could not be determined.The sheath puncture may have occurred due to the tip being pressed against the trachea, bronchi, esophagus, and surrounding organs, the scope being pushed while the sheath is pressed against the tissue, and the needle tip being caught on the sheath's bent position.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿·do not round the insertion tube smaller than 15 cm in diameter.The insertion tube may be damaged.·do not insert the needle forcibly, insert the needle while it is not fully retracted into the tube, or insert it rapidly.It may suddenly protrude from the tip of the endoscope, resulting in perforation, pneumothorax, major bleeding, mucous membrane damage, or damage to the endoscope or this product.Also, if the resistance is high and insertion is difficult, return the angle of the endoscope until it can be inserted without difficulty.·do not press the tip of the insertion tube against the tissue in the body cavity with excessive force.Doing so may lead to perforation, pneumothorax, major bleeding, mucous membrane damage, etc., or damage to the product.·if you try to push the needle out of the tube with the tip of the insertion tube pressed against the tissue inside the body cavity or with the tip of the insertion tube buckled, resistance may increase.If there is a lot of resistance when pushing the needle out of the tube, do not force the needle out.If the tip of the tube is deformed and the needle is pushed out in this state, the needle may pierce the tube, leading to perforation, pneumothorax, major bleeding, damage to the mucous membrane, etc., and damage to the endoscope.¿ 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: 16273643
• Report Number: 9614641-2023-00139
• Device Sequence Number: 20705940
• Product Code: GAA
• UDI-Device Identifier: 04953170196669
• UDI-Public: 04953170196669
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: CLASS1-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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-401D-1321
• Device Lot Number: 2K8193
• Was Device Available for Evaluation?: Yes
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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: BROCHOSCOPE
• Patient Sex: Unknown