Recall Z-2676-2016 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use.
| Date | Aug 26, 2016 (initiated Jul 14, 2016) |
| Status | Terminated |
| Reason | Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening. |
| Root cause | Nonconforming Material/Component |
| Action | Intuitive sent a Stop Use e-mail to all affected sites on July 14, 2016 to inform users of the issue prior to the commencement of a recall. E-mail described the problem and asked that all surgeons who use the stapler be informed to immediately stop use. Formal letters will follow. Medical Device Recall letters were sent on July 21, 2016. Customers were instructed to return quarantined affected product whether used or unused to Intuitive Surgical. Customers should contact customer service to initiate the standard Return Material Authorization (RMA) process by phone or email: North and South |
| Quantity | 875 instruments (827 a la carte + 48 in kits) total, all models |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140553 | ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS Intuitive Surgical, Inc., Jul 25, 2014 |