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

Model Number	NA-201SX-4021
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In speaking with olympus technical support via the phone, the olympus representative stated the customer was going to return the out of box failure device back to olympus for evaluation.Additional information was requested from the reporter.A supplemental report will be submitted should additional information be made available.The subject device has been received and is currently in the evaluation process.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The olympus representative reported on behalf of the customer, during a therapeutic procedure, while using the single use aspiration needle, the biopsy port was leaking and spraying water.No patient injury reported.The same issue occurred at the facility with two (2) separate patients on the same day using a new single use aspiration needle.This complaint is related to patient identifier: (b)(6).
Event or Problem Description
Additional information was provided by the reporter.The issue occurred in the beginning of an endobronchial ultrasound (ebus) procedure.An ebus bronchoscope was being used with the single use adapter biopsy valve and single use aspiration needle.No other devices were involved in the event.There was no surgical delay.The intended procedure was completed with the same device.The device was inspected prior to use and appeared intact and good.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the reporter.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.Since the production lot number of the device (maj-1414) was unknown, the device history records (dhr) was reviewed for about one year from the date of occurrence (august 2020 to july 2021).The event was inspected related to the indicated event.There was no abnormality with the device.The root cause of the issue could not be conclusively specified.It was likely the issue occurred might be the following: ·the rubber of the biopsy valve was damaged or deformed by attaching / detaching the needle aspiration and the syringe during the procedure.·the biopsy valve was not placed properly to the endoscope.Corrected data: d9.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation.The evaluation results do not impact the reported investigation results.The olympus service center was unable to replicate the user's event.The evaluation found a kink approximately 200mm from the boot.Additionally, there is also a bend near the distal end side.The opening of the insertion portion at the distal end has foreign material built up.The handle section has a slight indentation on the needle slider.The needle adjuster, needle adjuster lever, stopper, connector section is all normal.The sheath adjuster knob is normal, and its lock function works as intended.Inspected the connector at the biopsy valve and port and confirmed that no fluid spilled out from this location.

• 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: 12341683
• Report Number: 8010047-2021-10478
• Device Sequence Number: 11791165
• Product Code: FCG
• UDI-Device Identifier: 04953170381911
• UDI-Public: 04953170381911
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/29/2022

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: 12V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 08/19/2021; 09/29/2021; 02/28/2022
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/07/2021; 10/14/2021; 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EBUS BRONCHOSCOPE, MODEL # BF-UC180F-A; SINGLE USE ADAPTER BIOPSY VALVE, MODEL # MAJ-1414
• Patient Sex: Unknown