Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Summary
The FDA issued a Class II for Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Mode by Intuitive Surgical, Inc.. Reason: Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that.
Details
Source
Device Recall
External ID
Z-1518-2024
Action Date
2024-04-17
Status
Ongoing
Category
device
Product Description
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Lot/Code Info: Part/UDI-DI: 380601/00886874114605. SP1098 Serial Numbers: SP0202, SP0253, SP0254, SP0219, SP0228, SP0231, SP0238, SP0273, SP0208, SP0226, SP0240, SP0247, SP0249, SP0256, SP0257, SP0268, SP0270, SP0272, SP0221, SP0223, SP0225, SP0229, SP0230, SP0232, SP0233, SP0235, SP0236, SP0237, SP0239, SP0241, SP0242, SP0243, SP0244, SP0245, SP0248, SP0250, SP0251, SP0252, SP0255, SP0258, SP0259, SP0260, SP0261, SP0262, SP0263, SP0264, SP0265, SP0266, SP0269, SP0274, SP0278, SP0280, SP0282
Quantity Affected: 53
Reason for Recall
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
Distribution
US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV, MS, TX, KS. OUS: China, France, Japan, South Korea
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-13
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 171 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-1518-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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