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

Model Number 1882923

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 03/28/2022

Event Type  malfunction  

Event Description

Microlaryngeal shaver blade stopped working during case.

• Brand Name: SKIMMER MICROLARYNGEAL SHAVER BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 14041779
• MDR Text Key: 288782433
• Report Number: 14041779
• 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: 04/04/2022

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
• Device Model Number: 1882923
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1