{ "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": "2955842-2013-03460", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130910", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121017", "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": "20130911", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "453038", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130910", "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": "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": "20250725", "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": "20130910", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "29 YR", "patient_sex": "", "patient_weight": "57", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Hemorrhage/Blood Loss/Bleeding", "Thrombus" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3340334", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "3868490", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION,INCLUDING MEDICAL RECORDS AND OPERATIVE REPORTS OF A PATIENT WHO UNDERWENT A ROBOTIC SUPRA-CERVICAL HYSTERECTOMY ON (B)(6) 2012. DURING THE PROCEDURE,THE OPERATIVE REPORT NOTED THAT SOME SMALLER BRANCHES OF THE UTERINE ARTERIES WERE BLEEDING AND THESE WERE COAGULATED. IT WAS ALSO REPORTED THAT THE CERVICAL STUMP WAS OOZING AND A V-LOC RUNNING SUTURE WAS USED TO OBTAIN HEMOSTASIS. THERE WAS A SMALL AMOUNT OF OOZING NOTED IN THE MIDLINE REGION OF THE BLADDER AND FLOSEAL WAS PLACED IN THE AREA. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME AS OUTPATIENT. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2012 WITH COMPLAINTS OF ABDOMINAL PAIN. CT SCAN SHOWED FREE-FLUID NEAR BLADDER. PATIENT UNDERWENT CYSTOSCOPY, DIAGNOSTIC LAPAROSCOPY AND EXPLORATORY LAPAROTOMY ON (B)(6) 2012 WHICH FOUND A CYSTOTOMY, WHICH WAS REPAIRED. PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2012 WITH GROSS HEMATURIA. PER MEDICAL RECORDS, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR CYSTOSCOPY AND CLOT EVACUATION, THEN EXPLORATORY LAPAROTOMY WITH CLOSURE OF CYSTORRHAPHY AND PLACEMENT OF DRAIN. PATIENT RECEIVED BLOOD TRANSFUSION POST-OPERATIVELY. THE PATIENT'S URINE OUTPUT WAS CLEAR, HER WOUND CLEAN AND DRY AND SHE WAS DISCHARGED HOME ON (B)(6) 20012. PAST MEDICAL HISTORY FOR THIS PATIENT IS SIGNIFICANT FOR LAPAROSCOPIC BILATERAL TUBAL LIGATION (B)(6) 2011. CLINIC MEDICAL RECORDS INDICATE THAT THE PATIENT RETURNED TO CLINIC ON (B)(6) 2011, AND WAS FOUND TO BE FEBRILE WITH A 2.5-3CM PALPABLE FIRM MASS IN LOWER LEFT ABDOMEN, CONSISTENT WITH HEMATOMA OR INFECTION AT SURGICAL SITE." }, { "mdr_text_key": "11173858", "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. IF ANY ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. 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 HAS MADE AN ATTEMPT TO CONTACT THE SITE TO OBTAIN FURTHER CLINICAL INFORMATION; HOWEVER, AS OF DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL HYSTERECTOMY PROCEDURE. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED 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": "" } ] }