MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS QUADCUT; BUR, EAR NOSE

Catalog Number 1884380HR

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 03/12/2015

Event Type  malfunction  

Event Description

Unable to seat quadcut blade on the microdebrider handpiece.

• Brand Name: QUADCUT
• Type of Device: BUR, EAR NOSE
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st; fort worth TX 76137
• MDR Report Key: 4630215
• MDR Text Key: 17581473
• Report Number: 4630215
• Device Sequence Number: 2
• Product Code: EQJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/13/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 1884380HR
• Device Lot Number: 0209228812
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR