{ "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": "2955842-2013-03203", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130826", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20111212", "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": "20130826", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "415662", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130826", "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 A6.0P8", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20130826", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "45 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dysuria" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3306874", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "20982544", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON JULY 25, 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011 DUE TO PELVIC PAIN AND ENDOMETRIOSIS. THERE WAS NO ALLEGATION IN THE PATIENT'S OPERATIVE REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. DURING A POST-SURGICAL FOLLOW-UP EXAMINATION ON (B)(6) 2011 THE PATIENT COMPLAINED THAT SHE EXPERIENCED BURNING DURING URINATION. ON (B)(6) 2011 THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF FEVER, CHILLS AND ABDOMINAL PAIN. LAB TESTS PERFORMED REVEALED THAT THE PATIENT'S HAD A SUBSTANTIALLY ELEVATED WHITE BLOOD CELL COUNT SUGGESTIVE OF INFECTION. A CT SCAN SHOWED THICKENING OF THE RECTUM AND A CT SCAN WITH RECTAL AND ORAL CONTRAST WAS ALSO PERFORMED THAT SHOWED A SMALL COLLECTION IN THE PELVIS MEASURING APPROXIMATELY 3CM IN DIMENSION. NO EXTRAVASATION WAS NOTED. PER THE PATIENT'S MEDICAL RECORDS, THE PATIENT'S HEALTHCARE PROVIDERS MADE THE DECISION TO TREAT THE PATIENT WITH IV ANTIBIOTICS AND PLACED THE PATIENT ON A LIQUID DIET. THROUGHOUT THE PATIENT'S HOSPITALIZATION THE PATIENT CONTINUED TO BE TREATED WITH ANTIBIOTICS AND CLOSELY MONITORED. ON (B)(6) 2011 THE PATIENT WAS RESPONDING WELL TO TREATMENT AND WAS CONTINUING TO IMPROVE. REPORTEDLY, THE PATIENT WAS AFEBRILE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011." }, { "mdr_text_key": "21141937", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED IN THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE INFECTION THAT THE PATIENT DEVELOPED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED AN INFECTION POST OP DA VINCI SI HYSTERECTOMY PROCEDURE." } ], "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": "" } ] }