MAUDE Adverse Event Report: COVIDIEN, INC. SUPERDIMENSION NAVIGATION SYSTEM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Device Inoperable (1663); Reset Problem (3019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2016

Event Type  malfunction  

Event Description

Prior to procedure, the patient's ct scan was introduced into the navigational laptop.Lesion of choice was located in the lingular segment of the left upper lobe.Navigational plan was formulated and exported to the jump drive.Jump drive was then introduced into the main navigational computer.Procedure was then begun.Bronchoscope was introduced into existing endotracheal tube.Endobronchial ultrasound balloon was then inflated.Lesion was visualized distal to the vessels.Endobronchial ultrasound was initially removed without biopsy.Locatable guide was introduced.All airways from that navigation was begun; however, navigational computer malfunctioned, and was unable to navigate due to hard drive failure despite multiple attempts at rebooting computer.The physician then used the navigational catheter and radial probe to visualize the mass in the left upper lobe.The navigation catheter was removed and endobronchial ultrasound scope was reinserted.Biopsies were then attempted into the deep left upper lobe mass.The patient tolerated the procedure well.There was no bleeding, and no post-operative chest pain.Post-operative chest x-ray was without pneumothorax or evidence of other complication.

• Brand Name: SUPERDIMENSION NAVIGATION SYSTEM
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN, INC.; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 5513274
• MDR Text Key: 40743666
• Report Number: 5513274
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR