MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX

Model Number NA-U401SX-4022

Device Problem Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/24/2022

Event Type  Injury  

Event Description

The customer reported during an unknown procedure, the aspiration needle at the end was lost and fell into the patient's lung.It dislodged in the lung and was retrieved with forceps.During retrieval, the needle fell again, close to the patient's esophagus, in their airway.The needle was retrieved again and removed from the patient.The customer was unaware of any additional issues with the patient.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• Type of Device: 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: 14189632
• MDR Text Key: 290786010
• Report Number: 2951238-2022-00388
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170388323
• UDI-Public: 04953170388323
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/25/2022,04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4022
• Device Lot Number: KR212645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other