MAUDE Adverse Event Report: OLYMPUS AMERICA INC. OLYMPUS ULTRASONIC PROBE; RADIAL ULTRASONIC PROBE

Model Number UM-S20-17S

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Positioning Problem (3009)

Patient Problems Arrhythmia (1721); Arrhythmia (1721); Cardiac Arrest (1762); Cardiac Arrest (1762); Death (1802)

Event Date 01/26/2017

Event Type  Death  

Event Description

The pt had a history of bronchiectasis and prior aspergillus infection.Ct on (b)(6) 2017 revealed a peripherally lobulated 3.0 x 2.1 x 3.1 cm central cavitary lesion with positive fdg activity raising a question of a neoplasm.Transbronchial biopsy was planned to identify the lesion.Heparin was discontinued prior to the procedure.Navigational bronchoscopy with a radial endobronchial ultrasound (ebus) was employed.After insertion of the ebus, there was difficulty pulling back the probe which was noted to be coiled at the end of the bronchoscope.The scope, probe and sheath were removed in toto without apparent problem and, were intact.The pt's oxygen saturations dropped.Blood was noted coming from the mouth.The bronchoscope was inserted through the endotracheal tube and blood suctioned with improved ventilation.Subcutaneous emphysema was noted and a chest tube was inserted.The pt developed a wide complex arrhythmia and arrested.A code was called.After 49 minutes of cpr, the code was discontinued and the pt expired.

• Brand Name: OLYMPUS ULTRASONIC PROBE
• Type of Device: RADIAL ULTRASONIC PROBE
• Manufacturer (Section D): OLYMPUS AMERICA INC.; center valley PA 18034
• MDR Report Key: 6332627
• MDR Text Key: 241267862
• Report Number: 6332627
• Device Sequence Number: 1
• Product Code: ITX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2017
• Distributor Facility Aware Date: 01/27/2017
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 67