Petition Seeks FDA Probe of Intuitive Surgical's da Vinci Device

A citizen petition is seeking a comprehensive safety investigation and potential recall of Intuitive Surgical's da Vinci Permanent Cautery Spatula, citing reports of mechanical and electrical component failures and a recent recall involving a related robotic surgical instrument.

In the 9/20 petition , Jennifer Nelson, a patient who reported a serious bowel injury following robotic surgery in 2017, asks FDA to determine whether the Permanent Cautery Spatula shares components, manufacturing processes or failure mechanisms with Intuitive's da Vinci S/Si Permanent Cautery Hook, which was subject to a Class II recall involving frayed or broken pitch cables.

The petition cites an FDA-announced recall initiated by Intuitive on 12/9/2025. According to the petition, FDA identified increased complaints involving frayed or broken pitch cables and listed process change control as the determined cause of the recall.

Nelson argues that the Hook recall warrants a renewed examination of the Permanent Cautery Spatula, another reusable electrosurgical instrument used with Intuitive's da Vinci robotic surgical system. The petition identifies numerous FDA Medical Device Report (MDR) submissions involving the Spatula, including reports of broken pitch cables, damaged conductor wires, insulation failures, thermal damage, detached instrument tips and component fragments entering patients.

One cited report involved separation of the distal instrument assembly during surgery, requiring conversion to an open procedure to retrieve the detached tip. Another described a fragment entering a patient's pericardium before being retrieved during the same operation.

Nelson acknowledges that individual MDR reports do not establish causation or demonstrate a systemic device defect. However, she argues that the reported failures warrant an engineering investigation to determine whether the Spatula and recalled Hook share underlying component vulnerabilities.

Nelson also asks FDA to revisit the circumstances surrounding a serious bowel injury she sustained following a 2017 robotic hysterectomy at Mayo Clinic during which a Permanent Cautery Spatula was used.

According to the petition, Intuitive Surgical subsequently informed Nelson that the da Vinci system had not malfunctioned. Nelson is asking FDA to determine whether that conclusion was supported by a documented engineering investigation of the actual instrument used during her procedure.

The petition requests that FDA examine surgical photographs, operative records, expert testimony and other evidence generated during subsequent litigation involving Mayo Clinic to determine whether the instrument may have experienced an electrical, mechanical or thermal failure.

Nelson previously filed a citizen petition in 2018 requesting FDA action concerning Permanent Cautery Instruments. She contends that subsequent adverse-event reports and the 2026 Hook recall provide additional evidence warranting a new investigation.