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

Device Problems Overheating of Device (1437); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

Xomed shaver was making a "funny noise" and was heating up.The drill was tagged down & replaced.

• Brand Name: XOMED SHAVER
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 15319314
• MDR Text Key: 298887895
• Report Number: 15319314
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2022

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: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Male
• Patient Weight: 97 KG