Reported Jan 31, 2018 · Terminated
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- daVinci X EndoWrist(R) Stapler 45
- REF 470298 Product UsageThe Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci 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 the same staple line or tissue buttressing material (natural synthetic)
- Lot codes and dates
- UDI 00886874112427Serial
- Numbers
S10170630S11170705S10170707S10170731
- Amount recalled
- 60 units
Where it was sold
- Nationwide
Why it was recalled
Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.
This product could cause temporary or reversible health problems — stop using it.
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