{ "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": "2955842-2013-03515", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110712", "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": "20130912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "460015", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "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": [ "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": "20250810", "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": "20130912", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "44 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Hemorrhage/Blood Loss/Bleeding", "Urinary Retention", "Physical Entrapment", "Impaired Healing" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345897", "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": "17132594", "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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2011. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF A SYMPTOMATIC FIBROID UTERUS, WITH A LARGE FIBROID ON THE RIGHT SIDE OF THE UTERUS. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON STATED THAT DURING DETACHMENT OF THE FIBROID FROM THE RIGHT SIDE OF THE PATIENT'S PELVIC SIDEWALL, BLEEDING WAS NOTED COMING FROM A FEEDING VESSEL OF THE FIBROID. HEMOSTASIS WAS ACHIEVED WITH CLIP PLACEMENT. FIBRILLAR WAS ALSO PLACED FOR HEMOSTASIS. THE OPERATIVE REPORT DESCRIBES THE USE OF A LAPAROSCOPIC CAMERA, AND AN ENDOSCOPE MORCELLATOR THROUGH A 12 MM PORT. AFTER THE PATIENT'S UTERUS WAS REMOVED AND THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH URINARY RETENTION. PER OPERATIVE REPORTS, A CT SCAN WAS PERFORMED WHICH SHOWED A PELVIC ABSCESS AND PARTIAL COMPRESSION OF THE RIGHT URETER. ON (B)(6) 2011, THE PATIENT UNDERWENT BILATERAL URETERAL STENT PLACEMENT THROUGH A CYSTOSCOPY PROCEDURE. DURING THE SAME GENERAL ANESTHETIC, THE PATIENT HAD AN OPEN PROCEDURE, THROUGH A LOW-MIDLINE INCISION, TO EXPLORE HER ABDOMEN/PELVIS AND DRAIN THE ABSCESS. A RIGHT SALPINGO-OOPHORECTOMY AND MECKEL'S DIVERTICULECTOMY WERE ALSO PERFORMED DURING THIS PROCEDURE. THE SURGEON DESCRIBES CAREFUL INSPECTION OF THE SMALL BOWEL AND COLON, AND NO INJURIES, LEAKAGE SITES, OR ENTEROTOMIES WERE FOUND. THIS WAS CONFIRMED THROUGH RIGID SIGMOIDOSCOPY PERFORMED BY A COLORECTAL SURGEON AT THE END OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURES WELL AND NO COMPLICATIONS WERE NOTED IN THE OPERATIVE REPORT. THE DATE OF DISCHARGE FROM THE HOSPITAL FOLLOWING THIS PROCEDURE WAS NOT PROVIDED. THE PATIENT'S POST-OPERATIVE COURSE FOLLOWING THIS PROCEDURE WAS COMPLICATED BY POOR WOUND HEALING AND SUBSEQUENT WOUND REVISION UNDER SEDATION ((B)(6) 2011). ALSO AT THIS TIME, THE PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY. THE PROCEDURE NOTES REPORT THE GALLBLADDER SHOWED CHANGES CONSISTENT WITH CHRONIC CHOLECYSTITIS AND THE CYSTIC DUCT WAS PARTIALLY TORTUOUS." }, { "mdr_text_key": "17357691", "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. 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 SI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL 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": "" } ] }