Device product
Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
Z-0887-2013
Product summary
- Firm
- Aesculap, Inc.
- Event
- Event 64407
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59
- Official record key
device-enforcement:Z-0887-2013
Official wording
Reason: The bipolar energy did not stop after release of the foot pedal.
Code information: Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12
Distribution pattern: USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.
Derived failure modes
-
Unknown
The bipolar energy did not stop after release of the foot pedal.