Device product
LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
Z-2427-2018
Product summary
- Firm
- Covidien LLC
- Event
- Event 79735
- Status
- Terminated
- Classification
- Class II
- Quantity
- 936
- Official record key
device-enforcement:Z-2427-2018
Official wording
Reason: Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
Code information: Lot #s 72550127X 72770140X 72770141X 73000048X
Distribution pattern: Worldwide Distribution in the countries of Australia, Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Swede, Switzerland and United Kingdom
Derived failure modes
-
Unknown
Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.