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

Model Number	NA-U401SX-4025N
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus, during an unspecified procedure, the unknown vizishot2 needle came out of the catheter/sheath and would not go back in.The physician was able to retrieve the needle from the patient although the patient's airway was scratched while removing the needed.The needle was extended into the lymph node.Since the physician was unable to pull the needle back, the entire endoscope was removed from the patient with the needle sticking out in order to retrieve it.There was minor injury to the patient as the needle was taken out of patient, but there was no sustained bleeding afterwards noted and no other immediate injury.Model na-u401sx-4025n was selected as a representative for the reported device: vizishot 2.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: 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: 14565679
• Report Number: 2951238-2022-00414
• Device Sequence Number: 12290555
• Product Code: KTI
• UDI-Device Identifier: 04953170402005
• UDI-Public: 04953170402005
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2022
• Report Date (Section F): 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NA-U401SX-4025N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2022
• 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: UNKNOWN BRONCHOSCOPE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown