Home / Recalls / Intuitive Surgical, Inc. / Z-0404-2018

Z-0404-2018 Class II Terminated

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
January 31, 2018
Initiation Date
September 19, 2017
Termination Date
January 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60 units

Product Description

daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The 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).

Reason for Recall

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.

Distribution Pattern

US Nationwide Distribution

Code Information

UDI 00886874112427: Serial Numbers: S10170630, S11170705, S10170707, S10170731

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