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SureForm recallZ-0340-2023 · Intuitive Surgical, Inc. · initiated Oct 7, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential staple deployment failure and device fragment generation

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 10/07/2022, Intuitive Surgical communicated an "Urgent Product Safety Notice" email to "STOP USE of da Vinci Xi 8mm SureForm 30 Stapler Instruments (488530-10) and Reloads (48230M-02, 48230W-02, 48230B-02)" and informing customers that there is a potential to transect targeted tissue without stapler formation that could result in bleeding and potential to generate fragments when using these products. On or about 10/25/2022, the firm sent an "Urgent Medical Device Removal" Letter via FedEx that informed their customers of the STOP USE. Customers are instructed to: Locate and return all affected products, as listed above, in their inventory via the standard RMA process by calling Intuitive Customer Service at (800) 876-1310, Option 3, 4 AM to 5 PM PST. If they have shared these products with other sites, make sure appropriate staff at that site receive and understanding this notification so that they locate and return their affected product. Customers may continue to use the da Vinci 12mm SureForm 45/60 instruments and reloads, as well as EndoWrist Stapler instruments and reloads, as these instruments are not impacted by this issue and use a different technology to effect stapler formation. For questions or further information: Contact their Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: - US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]

Recall details

Recall number
Z-0340-2023
Status
Open, Classified
Initiated by the company
Oct 7, 2022
Posted by the FDA
Nov 30, 2022
Recalling firm
Intuitive Surgical, Inc.
Quantity
160 boxes of 488530-10 = 960 individual instruments 602 reload boxes = 7224 individual reloads
Product code
NAY
FDA submissions
K211997
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

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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