MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX

Model Number NA-U401SX-4021

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/08/2019

Event Type  Injury  

Event Description

It was reported that a vizishot of unknown lot-u401sx-4021 was used to perform an endotherapy procedure (b)(6) 2019.It is unclear if the healthcare provider noticed that the needle was broken during the procedure.The physicians did not experience any problem with the needle or the endoscope used during the procedure.The procedure was successfully completed using the same set of equipment.The user facility believed that the vizishot broke off in the patient but they were unable to confirm.On the (b)(6) 2019 the patient was followed up on in the doctor¿s clinic as part of the post-op follow up; the doctor learned that the patient was experiencing fever and with symptoms of asthma and pneumonia.The patient returned to the hospital on the (b)(6) 2019; the patient was admitted in er for another endobronchial ultrasound procedure, chest x-ray and ct-scan was performed.Based on the chest x-ray they observed a ¿bright linear structure¿ like a foreign object in the same lymph node that was biopsied on (b)(6) 2019.The ct-scan was not clear and it was difficult to tell if the linear structure was a foreign object.The patient was administered an antibiotic and was kept in the hospital; the patient was discharged on (b)(6) 2019 and reported to have an improved condition.On the (b)(6) 2019 the patient was still reported to be sick and experiencing fever and returned again in the hospital.The patient was admitted in the hospital again and was kept in the hospital until (b)(6) 2019.The physician stated that the patient was reportedly asymptomatic since (b)(6) 2019.No additional surgery or procedure was performed.On (b)(6) 2019 the patient returned to the hospital again to have a repeat ct-scan; the ct-scan was performed to evaluate the patient¿s condition again and for the physician had to determine if a surgical extraction needed.The ct-scan revealed that the patient¿s lymph node was almost normal and they had better visibility now of the foreign object in the patient¿s lymph node.The doctors decided to have the patient return to surgery for removal of the object.Surgery was scheduled for an outpatient procedure on the (b)(6) 2019.The physician found the broken needle that was inside the patient and removed it from the patient.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• 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
• MDR Report Key: 9246951
• MDR Text Key: 178593912
• Report Number: 2951238-2019-01171
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/03/2019,10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 89