Intuitive Surgical, Inc.

Arm drapes used with Intuitive Surgical's da Vinci SP robotic surgical system may detach from the instrument arm due to a defect in the drape rings at the top of the product. If a drape detaches during surgery, it can expose part of the instrument arm and may delay the procedure or require switching to an alternative surgical approach.

Certain Da Vinci surgical systems were distributed with a defective E-brake retainer pin. If the structural column fails, this pin can prevent the E-brake from engaging, potentially causing uncontrolled motion of the robotic arm. The pin may also loosen or back out, restricting arm movement or causing uncontrolled motion that could injure patient tissue.

Intuitive Surgical is recalling certain da Vinci S and Si reusable cautery hook surgical instruments (model 420183) because the internal pitch cables that control the instrument tip can fray or break during use. This could affect the surgeon's ability to control the instrument during a procedure. No injuries have been reported.

Intuitive Surgical is recalling certain da Vinci S and Si Tenaculum Forceps instruments (Model 420207) because the internal pitch cables that control the instrument tip can fray or break during use. This could affect the surgeon's ability to control the instrument properly during a procedure. No injuries have been reported so far.

Intuitive Surgical has recalled certain da Vinci S and Si Grasping Retractor instruments (Model 420278) due to reports of broken or frayed grip cables. The cables transmit motion from the surgeon's controls to the instrument tip during minimally invasive surgery. A cable failure could affect the surgeon's ability to control the instrument during a procedure.

Intuitive Surgical has recalled certain da Vinci S and Si Mega Needle Driver surgical instruments due to complaints of broken or frayed grip cables. These cables transmit motion from the surgeon's controls to the instrument tip inside the patient. The issue affects specific batch numbers manufactured between 2010 and 2018.

Intuitive Surgical has recalled certain da Vinci S and Si Double Fenestrated Grasper reusable surgical instruments due to reports of broken or frayed grip cables. The cables transmit motion from the surgeon's input to the instrument tip inside the patient. A cable failure during surgery could compromise the surgeon's ability to control the instrument.

Intuitive Surgical is recalling specific batches of da Vinci S and Si Monopolar Curved Scissors (model 420179) used in robotic surgery systems. The grip cables inside these instruments can break or fray during use, which could affect the surgeon's ability to control the instrument during a procedure.

A software update (version P1.2.1) for the Intuitive Surgical Da Vinci 5 surgical system can cause the user interface to disappear from external or tower monitors during use. This affects 12 systems distributed in six U.S. states. No injuries have been reported.

Certain da Vinci 5 Surgeon Console Viewer Displays have outdated firmware that may cause loss of the 3D surgical display or both displays entirely during surgery. When this happens, the surgical instruments remain active even though the surgeon cannot see the surgical field, which could result in unintended tissue contact, bleeding, or injury.

A software error allowed robotic instrument arms with bent or misaligned parts to remain in use during surgery. These parts can wear out and potentially fail during a procedure. Intuitive Surgical identified specific serial numbers of affected systems.

Intuitive Surgical has recalled certain Ion Vision Probe Bags (model 490127) because the sterile pouch seal may be compromised or incomplete. These bags are used to store the Vision Probe during lung biopsy procedures. A compromised seal could allow contamination of the sterile device.

Intuitive Surgical is recalling certain da Vinci SP Access Port Kits because the sterile trays may develop cracks during storage or handling. A cracked tray could allow bacteria or other contaminants to enter, compromising the sterile field during surgery. No injuries have been reported.

A faulty motor connector in certain da Vinci 5 surgical systems may cause Error 23062, which locks the surgeon console's ergonomic adjustments (viewer, headrest, armrest, and pedal position). This could delay or disrupt a scheduled surgical procedure. The issue affects 144 systems across 30 states.