U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable.
조치
Consignees were first notified by phone with a follow up e-mail or fax. The consignees were asked to complete the response section regarding the destruction/return of the device.
For questions regarding this recall call 425-882-1179.
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" || Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) || It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.