FDA recall Z-0249-2020

Intuitive Surgical, Inc. · Class II · device

Product

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

Reason for recall

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.

Distribution

Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.

Key facts

Status: Ongoing
Initiation date: 2018-06-04
Report date: 2019-11-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0249-2020