Recall Z-0249-2020 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
| Date | Jun 4, 2018 |
| Status | Open, Classified |
| Reason | The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation. |
| Root cause | Process change control |
| Action | On 06/04/2018, Medical Device Recall notices (Field Safety Notice Urgent Medical Device Correction- ISIFA2018-09-C) were emailed to U.S. consignees, and on 06/07/2018 notices were mailed via FedEx. Additionally on 06/08/2018 two (2) distributors received the notices via email and on 06/15/2018 two (2) EMEIA consignees received the notices by mail. The firm posted information regarding the voluntary field recall on their US Customer Portal on 06/04/2018. Customers were asked to: 1. Stop-use of the affected products for intra-cardiac procedures until further notice from the Recalling Firm. 2 |
| Quantity | 3108 units (518 boxes of 6 units) |
| Distribution | Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162973 | EndoWrist Suction Irrigator Intuitive Surgical, Inc., Feb 6, 2017 |