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

Model Number	NA-201SX-4021
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In speaking with olympus technical support via the phone, the olympus sales representative stated the facility would return the damaged device for credit.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to olympus that the single use aspiration needle bent during a diagnostic procedure.When the needle was being used, there was some resistance when passing through a node.The needle had bent when retrieved.A second needle was used to complete the procedure.No patient harm was reported.
Event or Problem Description
Additional information was received from the user facility.The vizishot needle was passed through the bronchial scope several times and then the surgeon noted that the needle was bent.There was no delay in the procedure.Another needle was opened, and the case preceded without any issues.Upon setting up for the case, no defect was noticed.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the user facility.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.The device history records for this device were reviewed.There were no abnormalities in the inspection items related to the indicated event (the needle tube was bent).The device manufacture date was january 2021.The root cause could not be identified.It was likely the (buckling of the needle tube) was caused by the following factors: ·when removing from the tray, a bending load was applied to the needle tube.·during the pre-use inspection, a bending load was applied to the needle tube.·when inserting into the endoscope, a bending load was applied to the needle tube.The instructions for use (ifu) provides the following guidelines: do not force the instrument if resistance to insertion is encountered.Reduce the angulation of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or 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: 11921407
• Report Number: 8010047-2021-07001
• Device Sequence Number: 3179965
• Product Code: FCG
• UDI-Device Identifier: 04953170381911
• UDI-Public: 04953170381911
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2021

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-4021
• Device Lot Number: 11V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/11/2021; 07/21/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/07/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRONCHIAL SCOPE, MODEL # UNKNOWN