{ "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": "2955842-2013-03316", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130830", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110504", "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": "20130830", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "430904", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130830", "brand_name": "DA VINCI S 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": "IS2000 A5.1P8", "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": [ "Insufficient Device Problem Information" ], "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": "20130830", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Anemia", "Dehydration", "Diarrhea", "Fever", "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Nausea", "Vomiting", "Fibrosis" ] } ], "distributor_city": "", "date_report": "20130805", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3319380", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130805", "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": "15602428", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. INTUITIVE SURGICAL INC. (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. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED DA VINCI S SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED AN INFECTED HEMATOMA AND REQUIRED IV ANTIBIOTIC TREATMENT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "15202311", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011. THE PATIENT WAS ADMITTED WITH THE DIAGNOSIS OF SYMPTOMATIC UTERINE FIBROIDS WITH ANEMIA SECONDARY TO ABNORMAL UTERINE BLEEDING. ACCORDING TO THE OPERATIVE REPORT, NEAR THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT RECEIVED INDIGO CARMINE AND A SPILL FROM THE BLADDER WAS OBSERVED. THE SURGEON THEN PLACED 180 ML OF METHYLENE BLUE DILUTED IN NORMAL SALINE INTO THE BLADDER AND NO LEAKAGES WERE OBSERVED FROM THE BLADDER OR THE URETERS INSIDE THE PELVIS. THE BLADDER WAS ALSO FOUND TO BE INTACT DURING A CYSTOSCOPIC EXAMINATION OF THE BLADDER. THE SURGEON NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND SHE WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. NO INTRA-OPERATIVE COMPLICATIONS WERE DOCUMENTED IN THE OPERATIVE REPORT. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL COMPLAINING OF ABDOMINAL PAIN ASSOCIATED WITH NAUSEA, VOMITING, AND DIARRHEA. THE PATIENT WAS ALSO FOUND TO HAVE PROFOUND DEHYDRATION AND LOW-GRADE FEVER. A CAT SCAN OF THE PATIENT'S ABDOMEN REVEALED MODERATE LEFT HYDRONEPHROSIS AND LEFT HYDROURETER WITH OBSTRUCTION. NO FREE FLUID OR FREE AIR WAS OBSERVED. AN INTERVENTIONAL RADIOLOGIST CONCLUDED THAT THE PATIENT HAD A POSSIBLE INFECTED HEMATOMA INSTEAD OF A PELVIC ABSCESS WHICH WAS INITIALLY SUSPECTED. AFTER RECEIVING IV ANTIBIOTICS, THE PATIENT'S CONDITION IMPROVED. SHE BECAME AFEBRILE, HER DIARRHEA WAS COMPLETELY RESOLVED, AND SHE DID NOT HAVE ANY COMPLAINTS OF TENDERNESS OF THE ABDOMEN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE DISCHARGE SUMMARY STATED THAT THE PATIENT WAS DOING CLINICALLY WELL AND SHE WAS TO BE DISCHARGED ON ORAL ANTIBIOTICS. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." } ], "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": "" } ] }