Recall Z-1814-2017 ยท GWG Endoscope, Neurological
Aesculap Implant Systems LLC
AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.
| Date | Mar 20, 2017 (initiated Mar 7, 2017) |
| Status | Terminated |
| Reason | Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode. |
| Root cause | Nonconforming Material/Component |
| Action | On March 15, 2017, 16 facilities and 1 Sales Rep were sent an Urgent Medical Device Recall Notification letter. Letters were sent Fed-Ex overnight. Customers were asked to immediately discontinue use and quarantine the product. A Sales Representative will remove the affected product and return to Aesculap Inc. |
| Quantity | 21 units distributed in U.S. |
| Distribution | Product was distributed throughout the United States and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983365 | AESCULAP MINOP SYSTEM Aesculap, Inc., Dec 18, 1998 |