Recall Z-1226-2015— Intuitive Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2015-02-16, terminated 2015-07-01. It names 2 FDA 510(k) clearances: K080291, K060391. Product: Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.. Reason: There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-16
- Terminated
- 2015-07-01
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K080291 — INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
- K060391 — INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.
Reason for recall
There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.
Data sourced from openFDA. This site is unofficial and independent of the FDA.