Device product
Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
Z-0479-2014
Product summary
- Firm
- Aesculap, Inc.
- Event
- Event 66533
- Status
- Terminated
- Classification
- Class II
- Quantity
- 85
- Official record key
device-enforcement:Z-0479-2014
Official wording
Reason: Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
Code information: all GN161's distributed between 4/28/2009 and 5/22/2013.
Distribution pattern: Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.
Derived failure modes
-
Unknown
Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.