Recall Z-1836-2016— Intuitive Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2016-05-09, terminated 2016-11-01. It names one FDA 510(k) clearance: K133845. Product: SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure.. Reason: Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-09
- Terminated
- 2016-11-01
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure.
Reason for recall
Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.