Recall Z-1951-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Encision, Inc.
AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is m
| Date | Jul 6, 2012 (initiated Jun 15, 2012) |
| Status | Terminated |
| Reason | Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures. |
| Root cause | Device Design |
| Action | Encision sent an Urgent Medical Device Recall letter dated June 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to lubricate the contact on the instrument cord with a conductive gel (to be supplied by Encision) prior to making the connection of the cord to the instrument. Instructions for applying the gel were attached. This corrective action was temporary; allowing customers to use their inventory of devices and for new product in the short term, until a design correction can resolve |
| Quantity | 48 boxes |
| Distribution | Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091074 | AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES Encision, Inc., Aug 17, 2009 |