Device product
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
Z-0561-2018
Product summary
- Firm
- Covidien LLC
- Event
- Event 79075
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0561-2018
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 10884521706606, Lot codes: S6MG007PX,S6MG010PX,S6MG016PX,S7AG002PX,S7BG005X,S7BG009X,S7DG004X,S7FG006X
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.