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

Model Number NA-201SX-4022

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/31/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports, the patient had an endobronchial ultrasound (ebus) procedure using a vizishot 19g, and a vizishot 22g needle.Both needles were required because the glands being biopsied were very hard.In the week following the procedure, the patient complained of coughing and not feeling well.The physician prescribed an antibiotic to fight suspected infection.Additional issue biopsies were need to confirm diagnosis of cancer, so a second ebus procedure was performed.During this second ebus procedure, a plastic part looking like the needle cover from a vizishot needle 22g, was seen.An attempt to retrieve the device fragment seen was made using the the scope currently in use for the ebus and unsuccessful.The physician changed to a bf-1th190 to retrieve the device fragment.This caused a 10 minutes delay in the procedure.The patient was sedated but not under general anesthesia and was aware of what was happening.The device fragment was removed successfully.The patient felt better right after the last procedure.No additional consequences to the patient were reported.The device fragment as been retained by the facility.It is not known at this time if it will be made available to olympus for evaluation.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h6, and h10.Physical evaluation of returned device sheath that was returned: only the broken sheath was sent., the sheath was broken at a position about 20 mm from the tip.Since the device lot number was unknown, the device history record (dhr) for the one year prior to the date of occurrence was inspected.No abnormalities were detected in the dhr for the following items which related to the reported phenomenon.·process inspection sheet.·quality inspection sheet.·nonconforming product report.Conclusion summary; the definitive cause of the reproted event could not be established the following can be considered from the analysis results and the evaluation of the device sheath that was returned: sheath rupture is considered to be ductile rupture due to overload.Considering the wrinkles and warpage of the broken sheath, it is presumed that the cause is a strong load that bends both the sheath and the coil passing through the inside.

• 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: 13638696
• MDR Text Key: 290922255
• Report Number: 8010047-2022-03727
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170389887
• UDI-Public: 04953170389887
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-201SX-4022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2022
• 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
• Treatment: VIZISHOT 19G NEEDLE.
• Patient Outcome(s): Other; Required Intervention