MAUDE Adverse Event Report: MEDTRONIC XOMED ROTATABLE FUSION BLADE TRICUT 13 CM; BURR, EAR, NOSE AND THROAT

Model Number 1884080EM

Device Problem Unintended Ejection (1234)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

Event Type  malfunction  

Event Description

After the completion of the image-guided fess, the rotatable fusion blade from the cutting burr was expelled from the barrel.The patient was not affected by this event.

• Brand Name: ROTATABLE FUSION BLADE TRICUT 13 CM
• Type of Device: BURR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED
• MDR Report Key: 6940176
• MDR Text Key: 89373603
• Report Number: MW5072672
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884080EM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 83