PlainRecalls
FDA Devices Moderate Class II Terminated

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).

Reported: September 7, 2016 Initiated: July 14, 2016 #Z-2675-2016

Product 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).

Reason for Recall

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.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
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,
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled? ▼
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).. Recalled by Intuitive Surgical, Inc.. Units affected: 875 instruments (827 a la carte + 48 in kits) total, all models.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2016. Severity: Moderate. Recall number: Z-2675-2016.

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