Recall Z-2767-2015— Nico Corp.

Name: FDA recall Z-2767-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-29

Class II · Terminated

Class II FDA medical device recall by Nico Corp., initiated 2015-07-29, terminated 2015-09-22. It names one FDA 510(k) clearance: K955168. Product: 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.. 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..

Recalling firm: Nico Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-07-29
Terminated: 2015-09-22
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K955168 — SURGICAL CUTTERPromex, Inc.·cleared 1996-01-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.