STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories 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 can be used with staple line or tissue butressing material (natural or synthetic).
Enforcement
- Recall Number
- Z-2675-2016
- Event ID
- 74811
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Intuitive Surgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- September 7, 2016
- Initiation Date
- July 14, 2016
- Classification Date
- August 26, 2016
- Termination Date
- January 3, 2017
- Address
- 1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States
Description
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories 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 can be used with staple line or tissue butressing material (natural or synthetic).
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.
All model 470298
Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,
875 instruments (827 a la carte + 48 in kits) total, all models