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Recall Observatory FDA recall evidence

Device product

INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B

Z-0340-2023

October 07, 2022

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 91080
Status
Ongoing
Classification
Class II
Quantity
160 boxes of 488530-10 = 960 individual instruments 602 reload boxes = 7224 individual reloads
Official record key
device-enforcement:Z-0340-2023

Official wording

Reason: Potential staple deployment failure and device fragment generation

Code information: Model Name / Model Number / UDI-DI Code: Da Vinci Xi 8mm SureForm 30 instruments 488530-10 10886874121723 Da Vinci Xi 8mm SureForm 30 Grey Reload 48230M-02 10886874121938 Da Vinci Xi 8mm SureForm 30 White Reload 48230W-02 10886874121921 Da Vinci Xi 8mm SureForm 30 Blue Reload 48230B-02 10886874121914 All Serial Numbers

Distribution pattern: U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. O.U.S.: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential staple deployment failure and device fragment generation