Recall Z-1048-2015 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
| Date | Feb 3, 2015 (initiated Jan 15, 2015) |
| Status | Terminated |
| Reason | The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time. |
| Root cause | Error in labeling |
| Action | Medical Device Recall Replacement letters were sent to all customers on January 15, 2015. The letter identified the reason for the recall, the risk to health, affected products, and actions to be taken by the customer or user and the firm. Customers were asked to discard the existing EndoWrist Stapler Documentation and replace it with the new Documentation provided by the firm. Intuitive Surgical will ship replacement instruments at no charge to customers. Then customers were asked to reunite the replacement instruments with the additional components. The firm will retrain customers on t |
| Quantity | 1,034 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123463 | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS Intuitive Surgical, Inc., Dec 3, 2012 |