Device product
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
Z-0558-2018
Product summary
- Firm
- Covidien LLC
- Event
- Event 79075
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0558-2018
Official wording
Reason: The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Code information: UDI 10884521189546, Lot codes: S5LG003PX,S5MG016PX,S5MG018PX,S6AG004X,S6AG005X,S6AG007X,S6BG004X,S6BG011X,S6BG015PX,S6BG017X,S6CG002X,S6CG008X,S6CG014X,S6CG015X,S6CG016X,S6DG002X,S6DG005X,S6DG007X,S6DG010X,S6EG004X,S6EG006X,S6EG008X,S6FG005X,S6FG008X,S6GG007X,S6GG010X,S6HG001X,S6HG003PX,S6HG008PX,S6HG009PX,S6HG012X,S6JG001X,S6KG003X,S6KG005PRX,S6KG005PX,S6KG009X,S6KG016X,S6LG002X,S6MG003X,S6MG018X,S7AG003X,S7BG012PCX,S7CG004X,S7CG006X,S7CG008PCX,S7CG010PCX,S7CG017X,S7DG002X,S7DG005X,S7EG006X,S7FG010PX
Distribution pattern: Nationwide including PR, Canada, China
Derived failure modes
-
Unknown
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.