MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

Model Number UM-S20-20R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Event Description

The service center received an article titled ¿endobronchial ultrasound-guided transbronchial lung biopsy in fluoroscopically invisible solitary pulmonary nodules.¿ the article reports that a prospective crossover study from january 2003 to january 2004, the purpose of the study was to assess whether endobronchial ultrasound ebus can help localize small, fluoroscopically invisible lesions.The study included all patients with solitary pulmonary nodule (spns) who were referred for diagnostic bronchoscopy were enrolled.All chest cts were reviewed, and the size of the lesions was recorded by their longest diameter.The procedures used in the study were in accordance with the recommendations found in the helsinki declaration of 1975.The article states that the institutional review board approved the study, and written informed consent was obtained in all patients, after which the patients underwent bronchoscopy.The procedures were performed under general anesthesia or conscious sedation.After a complete inspection of the bronchial tree, including the subsegmental bronchi, fluoroscopy was performed using a monoplanar c-arm.If the patient¿s lesion was visible fluoroscopically, the procedure was continued with transbronchial biopsy (tbbx) and was excluded from the trial.If the lesion could not be visualized by fluoroscopy, the patient was included in the trial and tbbx was performed under ebus guidance.According the author, one hundred thirty-eight consecutive patients with (spns) were examined.Of those, 54 patients presented with spns that were not visualized with fluoroscopy.The mean diameter of the nodules was 2.2 cm.In 48 patients (89%), the lesion was localized with (ebus), and in 38 patients (70%) the biopsy established the diagnosis.The 16 patients with undiagnosed spns were referred for surgical biopsy; 10 of those lesions were malignant and 6 were benign.The article states that a diagnosis was found in nine patients (17%) and as a result, they were saved them from having to undergo a surgical procedure.The only complication was a pneumothorax in one patient.The pneumothorax was treated by tube thoracostomy.The author reported that the study concluded that ebus could be added easily to perform tbbx and could help avoid aborting the procedure for lack of image guidance.In addition, it was indicated that ebus guidance is very effective in tbbx.Hearth, f.J.F., eberhardt, r., becker, h.D., & ernst, a.(2006).Endobronchial ultrasound-guided transbronchial lung biopsy in fluoroscopically invisible solitary pulmonary nodules: a prospective trial.Chest, 129,147-150.Https://doi.Org/10.1378/chest.129.1.147.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9545672
• MDR Text Key: 189244609
• Report Number: 2951238-2020-00301
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2019,01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UM-S20-20R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other