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

Model Number 1884005HRE

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/27/2016

Event Type  malfunction  

Event Description

Silver bullet tip broke inside patient nasal cavity.Surgeon had to retrieve broken tip.

• Brand Name: SILVER BULLET
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint dr. north; jax FL 32216
• MDR Report Key: 6089059
• MDR Text Key: 59479312
• Report Number: 6089059
• 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: 09/30/2016

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: Physician
• Device Model Number: 1884005HRE
• Device Catalogue Number: 1884005HRE
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 52 YR
• Patient Weight: 89