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

Model Number	NA-201SX-4021
Medical Device Problem Codes	Mechanical Problem (1384); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On customer follow up communication , the customer conveyed that there are no other information that could be provided, however, the device is being returned for evaluation.To date, the device has not yet been received for investigation.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
Customer reported that the device (aspiration needle device) came out of package broken, unable to switch to safety latch off to use the needle.There is no patient involvement on this reported event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to b5: the purpose of this medwatch report was clarified.Per the legal manufacturer, the customer's complaint of "device (aspiration needle device) came out of package broken, unable to switch to safety latch off to use the needle" has no potential to cause or contribute to death or serious injury if the malfunction were to recur.Correction to h3 - the device was not returned for investigation since it was lost during transit from olympus.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more less than 1 year since the subject device was manufactured.The exact cause of the problem could not be conclusively identified, since the device was not retuned for the investigation.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
This report was submitted because there may have been a hole or irregularity in the sealed sterile package.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: 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: 13944681
• Report Number: 8010047-2022-05273
• Device Sequence Number: 14605396
• Product Code: FCG
• UDI-Device Identifier: 04953170381911
• UDI-Public: 04953170381911
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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-201SX-4021
• Device Lot Number: 1YV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown