MAUDE Adverse Event Report: CIANNA MEDICAL INC. SAVISCOUT; RADAR LOCALIZATION

Model Number SCOUT CHECK

Device Problem Thermal Decomposition of Device (1071)

Patient Problems Burn, Thermal (2530); Bronchospasm (2598)

Event Date 07/15/2020

Event Type  Injury  

Event Description

Pt underwent needle localization savi scout procedure on (b)(6) 2020, without incident.After local anesthesia began to wear off, pt noticed burning sensation at site of procedure.Upon inspection, large burn noted at the site.

• Brand Name: SAVISCOUT
• Type of Device: RADAR LOCALIZATION
• Manufacturer (Section D): CIANNA MEDICAL INC. ; 6 journey ste 125; aliso viejo CA 92656
• MDR Report Key: 10338310
• MDR Text Key: 200882380
• Report Number: 10338310
• Device Sequence Number: 1
• Product Code: NEU
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCOUT CHECK
• Device Lot Number: CHK-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2020
• Distributor Facility Aware Date: 07/16/2020
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/20/2020
• 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: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 76 YR