da Vinci SP Surgical System Patient Cart Welds May Fail
Intuitive Surgical recalled 53 da Vinci SP Surgical System Patient Carts due to inadequate welds in the instrument arm joints. These welds may cause tissue injuries, conversion to open surgery, or user pinching injuries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with serious potential hazards including internal tissue injuries and conversion to open surgery, but no reported illnesses or injuries have occurred. This qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric's criteria for High (3) severity.
Plain-English summary
The da Vinci SP Surgical System Patient Cart (Part 380601, Model SP1098) has been recalled by Intuitive Surgical, Inc. The recall affects 53 units. The issue involves inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly, which is part of the instrument arm joints.
Inadequate welds in these components may cause two types of failures. Top belt failure can result in internal tissue injuries, body wall injury, or the need for emergent conversion to open surgery. Bottom belt failure may result in pinching injuries to the surgical user, though without harm to the patient.
In the United States, affected units have been distributed to California, New Hampshire, Florida, New York, Colorado, Alabama, Kentucky, Maryland, North Carolina, New Jersey, Ohio, South Carolina, South Dakota, Tennessee, Washington, Wisconsin, West Virginia, Mississippi, Texas, Kansas, and Virginia. Units are also distributed internationally in China, France, Japan, and South Korea.
Healthcare facilities that have this equipment should contact Intuitive Surgical, Inc. to verify whether their systems are affected by checking the serial numbers of their SP1098 units against the recall list. The manufacturer will provide guidance on corrective action.
The recalled product
- Product
- Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 53
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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