Quantum Surgical has launched a field safety corrective action for its Epione surgical robot in Europe due to a software defect that could misguide instrument placement during tumor ablation procedures.
The issue arises when users plan a strictly horizontal trajectory for needle insertion. Under these conditions, the robot may misalign its instrument guide, potentially risking internal injury. While no incidents or patient harm have been reported, the company is advising against horizontal trajectory planning until a software update is implemented.
Epione, used for minimally invasive treatment of abdominal tumors, has treated over 300 patients globally.
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