MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE

Model Number	NA-201SX-4022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.
Event or Problem Description
It was reported that during an endobronchial ultrasound (ebus), the needle became stuck in the tracheal wall and then broke.Subsequently the needle was retrieved.Although requested additional information has not been provided at this time.
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.The suspect device was not returned for evaluation and a conclusive root cause could not be identified.The exact cause of the needle break could not be identified, however, based on previously reported similar events, the legal manufacturer determined the needle tube likely broke off by the mechanism below: 1.The needle tube buckled significantly due to force to bend it, which was possibly generated by movements of the patient during the procedure.2.The buckled needle tube then received force to straighten it.3.The bending and straightening reduced the strength of the needle tube until it finally broke it off.As stated in the instructions for use, as a preventive measure: when inserting the instrument into the endoscope, the distal end of the needle tube may be bent.When piercing the target, confirm the distal end of the sheath and needle tube in the endoscopic field of view and/or ultrasound image while considering such bending.Otherwise, patient injury such as perforation, bleeding, or mucous membrane damage may occur.Do not try to straighten a bent or deformed needle with your hands because the needle may break.Use a spare needle instead.Do not push the needle slider suddenly.Doing so may cause sudden needle protrusion, resulting in perforation, bleeding, or mucous membrane damage.It can also damage the instrument.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10532319
• Report Number: 8010047-2020-06498
• Device Sequence Number: 11558936
• Product Code: FCG
• UDI-Device Identifier: 04953170180972
• UDI-Public: 04953170180972
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: 9ZV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1