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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.
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Manufacturer (Section D)
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
MDR Report Key9505923
MDR Text Key176416349
Report Number2951238-2019-01226
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
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 Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUM-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 Date11/25/2019
Event Location Hospital
Date Report to Manufacturer11/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/20/2019 Patient Sequence Number: 1