Da Vinci SI System - Patient Cart (2012-11-30)

Starting date:

November 30, 2012

Posting date:

December 4, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-36993

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  Reason
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  Affected products

Recalled products

A. Da Vinci SI System - Patient Cart 

Reason

During normal use of the robotic platform used for Da Vinci surgery (Patient cart), it can be exposed to small amounts of fluids from the environment (During cleaning for example) without impairing function. Improper cleaning techniques involving application of excessive amounts of fluid in a splashing or spraying manner can result in penetration of fluids inside the covers.  During procedures there is also a small risk that fluid can be transferred inside the patient cart ,for example, biological or I.V. fluids.

Affected products