ULTRASONIC PROBE UM-3R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-02 for ULTRASONIC PROBE UM-3R manufactured by Olympus Medical Systems Corp..

Event Text Entries

[185760600] 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. The article did not provide specific serial number for the referenced scope; therefore, it is unknown if the scope was returned to olympus for evaluation/service and a review of the instrument? S history could not be performed. 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2020-00293
MDR Report Key9539624
Date Received2020-01-02
Date of Report2020-01-02
Date Facility Aware2019-12-05
Report Date2019-12-05
Date Reported to Mfgr2019-12-05
Date Added to Maude2020-01-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameULTRASONIC PROBE
Generic NameULTRASONIC PROBE
Product CodeITX
Date Received2020-01-02
Model NumberUM-3R
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.