Recall Z-2770-2015 ยท GCJ Laparoscope, General & Plastic Surgery
Lumenis
Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
| Date | Sep 16, 2015 (initiated Jul 30, 2015) |
| Status | Terminated |
| Reason | There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue. |
| Root cause | Device Design |
| Action | Lumenis sent an Urgent Medical Device Recall letter on August 7, 2015, to all consignees. Consignees were instructed to destroy the operator manual, and return the affected device to Lumenis along with the completed Recall Verification form. Consignees with questions were instructed to call 801-656-2663. |
| Quantity | 54 devices with 108 hand pieces |
| Distribution | Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133272 | VERSACUT + TISSUE MORCELLATOR Lumenis, Ltd., May 13, 2014 |