Device product
Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
Z-0644-2013
Product summary
- Event
- Event 63842
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72 units
- Official record key
device-enforcement:Z-0644-2013
Official wording
Reason: Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.
Code information: Lot Number: 1179107
Distribution pattern: Worldwide Distribution - USA (nationwide) and France.
Derived failure modes
-
Unknown
Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.