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

Model Number UM-S20-17S

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Pneumothorax (2012)

Event Type  Injury  

Event Description

The service center received an article titled ¿cone beam computed tomography-guided thin/ultrathin bronchoscopy for diagnosis of peripheral lung nodules: a prospective pilot study.¿ the author states that the facility participated in a prospective pilot study of bronchoscopy for peripheral lung nodules under general anesthesia with thin/ultrathin bronchoscope, radial-probe endobronchial ultrasound (rp-ebus), and cbct.Main objective was to estimate radiation dose and secondary objective was the additional value of cbct in terms of navigational and diagnostic yield.According to the author, between february 2017 and february 2018, a total of 20 patients were enrolled.Median lesion size was 2.1 (range, 1.1-3) cm and distance from pleura was 2.1 (range, 0-2.8) cm."bronchus sign" was present in 12 (60%) of the lesions.Totally, 12 lesions (60%) were invisible on fluoroscopy.Cbct identified atelectasis obscuring the target in 4 cases (20%).The article states that eleven patients (55%) underwent 1 cbct scan and 9 patients (45%) 2.The mean estimated effective dose (e) to patients resulting from cbct ranged between 8.6 and 23 msv, depending on utilized conversion factors.Both pre-cbct navigation and diagnostic yield were 50%.Additional post-cbct maneuvers increased navigation yield to 75% (p=0.02) and diagnostic yield to 70% (p=0.04).During the study, one patient developed a pneumothorax that was treated with a chest-tube insertion.Reportedly, the pneumothorax was not present during cbct acquisition or post-procedure chest x-ray, but it was found 24 hours later when the patient presented with mild chest pain and dyspnea.According to the author, the results of the study suggested that the cbct-guided bronchoscopy was associated with acceptable patient radiation dose, and that the addition of cbct may potentially increase both navigation and diagnostic yield of thin/ultrathin bronchoscopy for peripheral lung nodules.There was no mention of any device failure in the article.The article does not provide a specific serial/lot number for mentioned devices (bf-p190, bf-xp190 and um-s20-17s).Therefore, it is unknown if any devices were returned to the service center for evaluation/service and a review of the instrument¿s history could not be performed.Casal, r.F., sarkiss, m., jones, a.K., stewart, j., tam, a., grosu, h.B., eapen, g.A.(2018).Cone beam computed tomography-guided thin/ultrathin bronchoscopy for diagnosis of peripheral lung nodules: a prospective pilot study.Journal of thoracic disease, 10(12), 6950¿6959.Doi:10.21037/jtd.2018.11.21.This is 3 of 3 reports.

• 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: 9505923
• MDR Text Key: 176416349
• Report Number: 2951238-2019-01226
• 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: 11/25/2019,12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention