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

Model Number SCOUT CHECK

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 06/29/2020

Event Type  Injury  

Event Description

Pt underwent needle localization savi scout procedure on (b)(6) 2020.Facility made aware of burn occurring on the pt's left breast, described as a 3rd degree burn.

• Brand Name: SAVISCOUT
• Type of Device: RADAR LOCALIZER
• Manufacturer (Section D): CIANNA MEDICAL INC. ; 6 journey ste 125; aliso viejo CA 92656
• MDR Report Key: 10379308
• MDR Text Key: 202039288
• Report Number: 10379308
• 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: 07/30/2020,07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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: REF 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: 07/30/2020
• Distributor Facility Aware Date: 07/27/2020
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/30/2020
• 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: 53 YR