INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30
Summary
The FDA issued a Class II for INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 48853 by Intuitive Surgical, Inc.. Reason: Potential staple deployment failure and device fragment generation.
Details
Source
Device Recall
External ID
Z-0340-2023
Action Date
2022-12-07
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 160 boxes of 488530-10 = 960 individual instruments 602 reload boxes = 7224 individual reloads
Reason for Recall
Potential staple deployment failure and device fragment generation
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-07
Company
Sunnyvale, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intuitive Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intuitive Surgical, Inc. have FDA actions?
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0340-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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