MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. QUADCUT BLADE 4.3MM; BUR, EAR, NOSE AND THROAT

Model Number 1884380HR

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2021

Event Type  malfunction  

Event Description

Blade defective; handpiece vibrates uncontrollably when attempted to use.Md had two prior blades of this product to vibrate the same way.On (b)(6) 2021, md was preparing to do an endoscopic sinus septoplasty turbinate reduction; bilateral right sm resection.The blade for fess, endoscopic sinus surgery was defective.The hand piece vibrates uncontrollably.Two more blades were opened and md experienced the same shaking with the blades.Md states he had this same problem with blades on (b)(6) 2021.Md requested blades be returned to the company (medtronic).This issue was identified prior to use on the pt.Md used another type blade.

• Brand Name: QUADCUT BLADE 4.3MM
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 12513290
• MDR Text Key: 273091068
• Report Number: MW5104143
• Device Sequence Number: 3
• Product Code: EQJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/20/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1884380HR
• Device Lot Number: 0221618125
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 108