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.
This recall has been terminated (originally issued December 11, 2013).
- Company
- Aesculap Inc
- Recall Initiated
- September 10, 2013
- Posted
- December 11, 2013
- Terminated
- October 20, 2014
- Recall Number
- Z-0479-2014
- Quantity
- 85
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
Distribution
Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.
Lot / Code Info
all GN161's distributed between 4/28/2009 and 5/22/2013.
Root Cause
Device Design
Action Taken
Aesculap sent an Important Recall Notification letter dated September 23, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return affected product and receive replacement product or credit. An Inventory Sheet is attached and must be completed. For questions call 610-984-9265 or 610-984-9414.