da Vinci SP Surgical System Patient Cart Welds May Fail

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.

Category

Medical Device — Surgical Equipment

Hazard

• weld-failure
• tissue-injury
• surgical-conversion
• pinching-injury

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.

Distribution

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