MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. RADIALUX; RETRACTOR

Model Number	50-101-1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged female with history of breast cancer positive gene mutation.Having surgery for breast reconstruction and implant, the medtronic radialux lighted retractor would not turn on.No known harm to patient.

• Brand Name: RADIALUX
• Common Device Name: RETRACTOR
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek cir.; louisville CO 80027
• MDR Report Key: 10894090
• Report Number: 10894090
• Device Sequence Number: 11584339
• Product Code: GAD
• UDI-Device Identifier: 00763000280055
• UDI-Public: (01)00763000280055(17)230317(10)860D
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/19/2020
• Report Date (Section F): 11/19/2020

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
• Operator of Device: Health Professional
• Device Model Number: 50-101-1
• Device Lot Number: 860D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2020
• Patient Sequence Number: 1
• Patient Weight: 72
• Date Report Sent to FDA: 11/19/2020