—#160837

Product

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).

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K140553
Affected lot / code info: UDI 00886874112427: Serial Numbers: S10170630, S11170705, S10170707, S10170731

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.

Root cause (FDA determination)

Process control

Action the firm took

The firm initiated their recall by email on 09/19/2017 and followed with a letter delivered by FedEx on 09/20/2017. The notice requested the following actions: "Please take the following actions to ensure all affected personnel are fully informed of this Field Safety Notice. Forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who are involved with da Vinci procedures. 1.Using the lot numbers listed above, please locate and return all affected Staplers at your site via the standard RMA process. a. Credit will be provided for remaining uses on affected instruments returned to Intuitive Surgical. 2.Please log into the da Vinci Online Community field action resource to read and/or complete any requested actions related to this issue. a. https://www.davincisurgerycommunity.com/ 3.If you cannot access the da Vinci Online Community field action resource, please complete the attached Acknowledgement Form and return it via fax or email to Intuitive Surgical per the instructions contained in the Acknowledgement Form. 4.Please retain a copy of this letter and a copy of the Acknowledgement Form for your files."

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2017-09-19
Terminated: 2024-01-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160837. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.