{ "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": "2955842-2012-00105", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20120305", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120131", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120801", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120305", "brand_name": "DA VINCI SI SURGICAL 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": "IS3000 A6.0P6", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20120305", "sequence_number_treatment": [ "DA VINCI SI SYS INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available" ] } ], "distributor_city": "", "date_report": "20130109", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2477080", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120209", "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": "2491297", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI SI PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL FOR A FASCIOTOMY TO REPAIR COMPARTMENT SYNDROME. PER THE ROBOTICS COORDINATOR PRESENT FOR THE CASE, THE DA VINCI SI SYSTEM DID NOT MALFUNCTION IN ANY WAY NOR CONTRIBUTE TO THE PATIENT'S OUTCOME, HOWEVER THE PATIENT WAS OBESE AND THE PROCEDURE TOOK LONGER THAN NORMAL. THE ROBOTICS COORDINATOR STATED THAT THE PATIENT'S POSITIONING AND DURATION OF THE PROCEDURE LIKELY CAUSED THE COMPARTMENT SYNDROME." }, { "mdr_text_key": "9652386", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE ROBOTICS COORDINATOR STATED THAT THE SYSTEM IN NO WAY CONTRIBUTED TO THE PATIENT INJURY. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI SI SURGICAL SYSTEM DID NOT MALFUNCTION AND DID NOT CONTRIBUTED TO THE PATIENT'S OUTCOME. THE HOSPITAL HAS CONTINUED TO USE THE DA VINCI SI SURGICAL SYSTEM TO PERFORM SURGERY ON PATIENTS. AS OF MARCH 2, 2012 NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S SYSTEM." }, { "mdr_text_key": "10454363", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "CORRECTED INFORMATION CAN BE FOUND IN SECTION TYPE OF REPORTABLE EVENT. INITIAL MDR WAS INADVERTENTLY SENT WITH INCORRECT INFORMATION IN TYPE OF REPORTABLE EVENT." } ], "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": "01/09/2013" } ] }