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

Model Number NA-201SX-4021

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 01/08/2021

Event Type  Injury  

Event Description

It is reported by a physician an unusual number of infections have occurred following procedures using a single use aspiration needle over a two to three month period.Additional information was requested from the customer multiple times.The customer stated they are unable to confirm the number of cases, any treatment required as a result of the infections, or if the single use aspiration needle caused or contributed to the infections.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• 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: 11272663
• MDR Text Key: 230077487
• Report Number: 2951238-2021-00295
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170389917
• UDI-Public: 04953170389917
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2021,02/03/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: NA-201SX-4021
• Device Lot Number: 9XV
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2021
• Date Report to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other