{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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Specifically, a vein adjacent to the kidney was damaged as a result of the unintended movement. The surgeon explained that during the procedure, his right hand slipped out of the right controller. Rather than the system freezing the movement of the controlled arm, the motion was mimicked when the controller was displaced downward within the surgeon console. Arm 3, which had a sharp scissor instrument installed, replicated the unintended movement, resulting in vascular injury to an adjacent vein. The surgeon confirmed that his head was positioned within the console viewer at the time of the incident and did not recall depressing the controller while the finger clutches were active. The vascular injury caused bleeding that necessitated a change in surgical plan. The procedure was converted from a partial nephrectomy to a radical nephrectomy, as the original plan to utilize clip appliers to achieve hemostasis was no longer feasible. Intuitive Surgical, Inc. (ISI) made multiple follow-ups attempts to obtain additional information; however, no further details have been received as of the date of this report." }, { "mdr_text_key": "16426248635", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "Intuitive Surgical, Inc (ISI) did not receive a da Vinci product to perform failure analysis. An ISI Technical Support Engineer (TSE) was contacted, and a system log review was performed at the caller's request; however, the logs did not indicate any errors or instrument engagement issues during the affected surgery." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 Central Expressway", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }