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

Model Number 1884380HR

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  malfunction  

Event Description

Patient was undergoing endoscopic sinus surgery, surgeon was using a quadcut 4.3mm (lot: 0224346224, ref 1884380hr) blade shaver and surgeon notice a difference while he was about to use it.Trial and error were made and identified that the blade was causing the shaking of the tip of the handpiece.Surgeon decided he cannot use it efficiently.Circulating nurse opened a new blade.Sales representative from the company was present when the incident happened and would do necessary reporting.

• Brand Name: QUADCUT®
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 15209980
• MDR Text Key: 297707357
• Report Number: 15209980
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/18/2022

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: 1884380HR
• Device Lot Number: 0224346224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1