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

Model Number	NA-U201H-8022
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Single use aspiration needle broke off in mass in pancreatic head during fine needle biopsy.Fda safety report id# (b)(4).

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 15242568
• Report Number: MW5111531
• Device Sequence Number: 12215166
• Product Code: FCG
• UDI-Device Identifier: 04953170402586
• UDI-Public: (01)04953170402586(17)250131(10)
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/14/2022

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-U201H-8022
• Device Catalogue Number: *SEE PHOTO PROVIDED
• Device Lot Number: 22K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: Black Or African American