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

Model Number NA-201SX-4021

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted to report the potential that a single use aspiration needle could have caused or contributed to a patient infection.The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238-2021-00295.

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.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h6 and h10.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.Correction and preventative action (capa ) investigation has been opened to further investigate this issue.Conclusion: it is reported that the infection potentially spread through the complaint device.Despite multiple attempts, details regarding the number of patients potentially affected could not be obtained.Based on the available information it is presumed that the reported event(s) were not caused by a defect or abnormality in the product.However, since the actual defective product could not be confirmed, it is not possible to identify the cause and event that occurred and the causal relationship between the product and the product.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it was reported that the infection spread from the content of the complaint, but it was not possible to obtain information on how the device affected and the infection.It is likely that the event was not caused by a defect or abnormality in the product.However, because the actual defective product could not be confirmed, it was not possible to identify the cause and event that occurred and the causal relationship between the product and the product.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "·the instrument is single-use, disposable item.Do not reuse or attempt to sterilize it.Reusing the instrument could pose an infection control risk and/or cause tissue irritation.In addition, the instrument¿s optimum functionality can only be realized during its first use" olympus will continue to monitor the field performance of this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11272712
• MDR Text Key: 233304276
• Report Number: 8010047-2021-02195
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170389917
• UDI-Public: 04953170389917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other