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

Model Number 1884005HRE

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/21/2016

Event Type  malfunction  

Event Description

While using the microdebrider to open the maxillary sinus, 5mm of the tip of the microdebrider broke off.The tip was seen in the maxillary sinus.We were able to retrieve the tip, despite active bleeding.The tip could have been sent down the nasal passage to the throat.

• Brand Name: SILVER BULLET
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville, FL 32216
• MDR Report Key: 5802670
• MDR Text Key: 49876236
• Report Number: 5802670
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/05/2019
• Device Model Number: 1884005HRE
• Device Catalogue Number: 1884005HRE
• Device Lot Number: 0210231869
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO.
• Patient Age: 33 YR
• Patient Weight: 123