Recall Z-2767-2015 ยท GEY Motor, Surgical Instrument, Ac-Powered
Nico Corp.
NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.
| Date | Sep 15, 2015 (initiated Jul 29, 2015) |
| Status | Terminated |
| Reason | Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. When these wires break or contact one another (i.e., short), various types of malfunction may occur with the console. One type of malfunction may result in unexpected aspiration increase. |
| Root cause | Process control |
| Action | The firm, Nico Corporation, sent an "URGENT: NICO Console Recall" notification dated 7/31/15 via fax to its customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The customers were instructed to return the console and complete and return the Recall Response Form via fax to: 317-683-0305 or email to: Jay.Dittman@niconeuro.com. The firm will provide customers with a Myriad Console loaner kit. If you have any questions, contact Director of Quality a |
| Quantity | 6 units |
| Distribution | US Distribution to states of: MD, IN, CA, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955168 | SURGICAL CUTTER Promex, Inc., Jan 22, 1996 |