{ "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": "2955842-2013-01254", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130416", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120314", "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": "20130417", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "162400", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130416", "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 A60.P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20130416", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Pain" ] } ], "distributor_city": "", "date_report": "20130318", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3062317", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130318", "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": "3338797", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, ISI RECEIVED A LEGAL COMPLAINT ALLEGING THAT A PATIENT WHOM UNDERWENT A DA VINCI SI GYNECOLOGICAL PROCEDURE ON (B)(6) 2012 AT (B)(6) MEDICAL CENTER IN (B)(6), EXPERIENCED PAIN, SUFFERING AND BLEEDING POST THE SURGICAL PROCEDURE. THE LEGAL COMPLAINT ALLEGES THAT UPON THE PATIENT'S FOLLOW UP WITH HER TREATING PHYSICIAN, THE PHYSICIAN INDICATED TO HER THAT THE POST-SURGICAL COMPLICATIONS SHE WAS EXPERIENCING WERE A NORMAL PART OF THE RECOVERY FROM HER SURGERY. THE LEGAL COMPLAINT ALLEGED THAT ON (B)(6) 2012 THE PATIENT MET WITH HER TREATING PHYSICIAN DUE TO EXTENSIVE GYNECOLOGICAL BLEEDING. IT WAS ALLEGED THAT THE TREATING PHYSICIAN DIRECTED THE PATIENT TO THE EMERGENCY ROOM AT (B)(6) MEDICAL CENTER. IT WAS DISCOVERED THAT THE PATIENT REQUIRED AN EMERGENCY SURGICAL PROCEDURE TO CORRECT A SURGICAL DEFECT THAT WAS CAUSED BY THE SITE'S DA VINCI SI SURGICAL SYSTEM. THIS WAS NOT DISCOVERED DURING THE PATIENT'S SURGICAL PROCEDURE PERFORMED ON (B)(6) 2012. REPORTEDLY, FOLLOWING THE EMERGENCY SURGICAL PROCEDURE, THE PATIENT WAS HOSPITALIZED AND CONFINED TO HER BED FOR MANY DAYS." }, { "mdr_text_key": "10626047", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE'S RISK MANAGEMENT DEPARTMENT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. ISI'S REVIEW OF THE SITE'S SYSTEM LOG FOR THE REPORTED PROCEDURE DATE FOUND THAT THERE WERE NO OCCURRENCES OF ANY SYSTEM ERRORS THAT CAUSED OR CONTRIBUTED TO THE ALLEGED INJURY SUSTAINED BY THE PATIENT." } ], "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": "" } ] }