Recall Z-1432-2013— Intuitive Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2013-05-08, terminated 2014-02-18. It names one FDA 510(k) clearance: K012833. Product: 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.. Reason: Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-08
- Terminated
- 2014-02-18
- 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
8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Reason for recall
Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
Data sourced from openFDA. This site is unofficial and independent of the FDA.