Improperly Tested da Vinci Surgical System Devices Prompts FDA Recall

Posted On: July 22, 2013 under

The Food and Drug Administration recently issued a class II recall of 30 devices that are part of the da Vinci Surgical System’s robots after finding that one of the testing devices wasn’t working properly. The FDA defines a class II recall as “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.” Intuitive Surgical, maker of the da Vinci system, notified physicians and hospitals itself of the potential problem with an Urgent Device Correction notice on June 27th; the recall affects the Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box, and Dual Camera Controller.

A spokesperson for Intuitive admits that one of the pieces of testing equipment malfunctioned, incorrectly recording results. However, Intuitive says that all 30 pieces affected by the recall were retested in the field, without any negative findings or any complaints filed. This might at first seem encouraging, but this is the second set of equipment malfunctions Intuitive has reported this year, the first being monopolar electricity arcing out of its Hot Shears Monopolar Curved Scissors (MCS) Instrument and burning patients’ internal tissue and organs during operations, sometimes causing significant damage.

Intuitive says it has posted all of its reported issues to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which tracks these types of things. However, submissions to MAUDE are voluntary, and often the cases remain uninvestigated. This leaves many in the medical community to wonder whether problems remain heavily underreported, leaving surgeons and patients without the full picture of what kind or level of concerns face them when using the da Vinci robot for surgery.

The FDA has been surveying surgeons and hospitals on the safety and efficacy of the da Vinci system since January of 2013 but has not yet filed a full report on its discoveries.

We would like to review any cases involving an individual who has been injured during a surgery that used the da Vinci Surgical System. These include all different kinds of surgery such as gynecological, urological, colorectal, cardiac, thoracic, and head and neck surgeries.