Incidents

A structured, sourced ledger of incidents involving deployed robots: collisions, injuries, recalls, regulatory actions, malfunctions, property damage, traffic disruption. Each entry is classified, attributed, and append-only; corrections and retractions are recorded on the record, never deleted.

• FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches2026-07-23 · regulatory_action
• FDA grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures2026-07-22 · regulatory_action
• FDA clears Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries2026-07-22 · regulatory_action
• FDA grants De Novo marketing authorization to J&J Ottava surgical robot2026-07-22 · regulatory_action
• FDA clears J&J Ottava surgical robot for US launch following de novo submission2026-07-22 · regulatory_action
• Medtronic Hugo surgical robot earns FDA clearance for additional indication2026-07-01 · regulatory_action
• LEM Surgical receives FDA clearance for Dynamis multi-arm surgical robot2026-07-01 · regulatory_action
• FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures2026-07-01 · regulatory_action
• ROBODOC Surgical System receives FDA 510(k) marketing clearance2026-06-30 · regulatory_action
• LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system2026-06-23 · regulatory_action
• Intuitive Surgical recalls da Vinci SP1098 instrument2026-06-22 · recall
• Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications2026-06-15 · regulatory_action
• Revolve Surgical receives FDA 510(k) clearance for surgical robot platform2026-06-15 · regulatory_action
• THINK Surgical receives FDA 510(k) clearance for TMINI 1.12026-06-15 · regulatory_action
• FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly2026-06-15 · recall
• CMR Surgical recalls Versius Surgical System consoles due to Secure Boot cybersecurity vulnerability2026-06-09 · recall
• Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death2026-05-28 · recall
• Medtronic Hugo RAS: failure to calibrate with the application program freezing or failing to launch (FDA MAUDE)2026-05-21 · malfunction
• Medtronic Hugo RAS: unintended collision with the application program freezing or failing to launch (FDA MAUDE)2026-05-14 · malfunction
• Medtronic Hugo RAS: bipolar grasper broke and dropped a resin insulator fragment into a patient (FDA MAUDE)2026-05-11 · injury
• Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)2026-05-08 · malfunction
• THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment2026-05-08 · recall
• Auris Monarch: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE)2026-04-30 · injury
• Intuitive Surgical recalls da Vinci staplers after death and injuries2026-04-15 · recall
• CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing open conversion (FDA MAUDE)2026-04-07 · malfunction
• FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab2026-04-06 · regulatory_action
• Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)2026-04-02 · recall