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

Model Number	NA-U401SX-4025N
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus, during an unspecified procedure, the unknown vizishot2 needle came out of the catheter/sheath and would not go back in.The physician was able to retrieve the needle from the patient although the patient's airway was scratched while removing the needed.The needle was extended into the lymph node.Since the physician was unable to pull the needle back, the entire endoscope was removed from the patient with the needle sticking out in order to retrieve it.There was minor injury to the patient as the needle was taken out of patient, but there was no sustained bleeding afterwards noted and no other immediate injury.Model na-u401sx-4025n was selected as a representative for the reported device: vizishot 2.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.The actual model number is unknown and was not provided by the customer.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2951238-2022-00414.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer's investigation.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer suspects the probable cause was: removal of the scope without the needle returning.There is a possibility that the needle tube did not return because it came off the suction port.The instruction manual contains the following descriptions, and it warns against this event.·do not coil the insertion portion with a diameter of less than 150 mm.Doing so could damage the instrument.·do not insert this instrument when the endoscope is angulated.This could damage the endoscope and/or this instrument.·do not force the instrument if resistance to insertion is encountered.Reduce the angulation of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: 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: 14565690
• Report Number: 8010047-2022-09179
• Device Sequence Number: 12032769
• Product Code: KTI
• UDI-Device Identifier: 04953170402005
• UDI-Public: 04953170402005
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K190239
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NA-U401SX-4025N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNKNOWN BRONCHOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown