MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. RAD; BUR, EAR, NOSE AND THROAT

Model Number	1884016
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic rad 60 extreme blade would not turn.New disposable obtained.

• Brand Name: RAD
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint dr. north; jax FL 32216
• MDR Report Key: 8084082
• Report Number: 8084082
• Device Sequence Number: 11151241
• Product Code: EQJ
• UDI-Device Identifier: 00681490047548
• UDI-Public: (01)00681490047548
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 11/08/2018
• Report Date (Section F): 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1884016
• Device Catalogue Number: 1884016
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/08/2018