{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2013-03944", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131004", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110107", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131004", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "503234", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131004", "brand_name": "DA VINCI SI SURGUCAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS 3000 A6.0P2", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250826", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20131004", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3385325", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "3770698", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON SEPTEMBER 4, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI NEPHRECTOMY PROCEDURE ON (B)(6) 2011 AND ALLEGED TO HAVE INJURIES TO THEIR KIDNEYS. NO FURTHER INFORMATION IS PROVIDED AT THIS TIME." }, { "mdr_text_key": "11219894", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT REPORTEDLY EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "24206227", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC RIGHT PARTIAL NEPHRECTOMY PROCEDURE. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES PATHOLOGY REPORT AND ANESTHESIOLOGY OPERATIVE LOG. THE PATIENT HAD A RESECTION OF A RIGHT RENAL MASS WHICH PROVED TO BE A RENAL CELL CARCINOMA. NOTHING IN THE OPERATIVE REPORT OR ANESTHESIA LOG APPEARED TO BE OUT OF THE ORDINARY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/01/2013" } ] }