Recall Z-2137-2012 ยท GCJ Laparoscope, General & Plastic Surgery
Transenterix, Inc
SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during a laparoscopic procedure under direct and/or endoscopic visualization.
| Date | Aug 3, 2012 (initiated Jul 2, 2012) |
| Status | Terminated |
| Reason | Some clip applier units may be inadequate to achieve clip closure. |
| Root cause | Process control |
| Action | TransEnterix sent an Urgent Device Recall letter date July 2, 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 check their inventory for affected product, remove the affected product from their inventory and either return it or dispose of it to prevent usage. Customers were instructed to complete the attached Inventory Reconciliation Formand return the form even if they no longer have any affected units in their inventory. Customers were instructed to ship the affected product to TransE |
| Quantity | 89 boxes(6 units per box) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Austria, Germany, Italy, Qatar and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091697 | SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 Transenterix, Inc., Sep 28, 2009 |