{ "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": "2955842-2012-01336", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20121217", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120309", "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": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20121218", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20121217", "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": "N", "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": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20121217", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Fatigue", "Pain", "Disability", "Abdominal Distention", "Weight Changes" ] } ], "distributor_city": "", "date_report": "20121118", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2876728", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20121118", "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": "3181077", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI SI HYSTERECTOMY PROCEDURE WAS FOUND POSTED ON THE DA VINCI STORIES ONLINE. HAD POP LEVEL 4 AND HYSTERECTOMY, LEAVING CERVIX ONLY, DONE ROBOTICALLY. STILL HAVE MAJOR ABDOMINAL PAIN AND BOWEL ISSUES. HE REMAINS TO TELL ME EVERYTHING OK. HAD CT SCAN SHOWING 9 MM KIDNEY STONE; SAID THIS IS REASON FOR PAIN. I'M HAVING THE SAME PAIN EXPERIENCED BEFORE SURGERY AND AFTER VAGINAL EXAMS. I FEEL BAD ALL THE TIME; NO ENERGY, BLOATING, AND WEIGHT GAIN. IF I TAKE FOUR ADVIL, IT HELPS, BUT IF ON MY FEET AWHILE, IT GETS WORSE... SO I SIT! I'M TIRED OF COMPLAINING TO DR AND FAMILY... NOT IN MY HEAD; THIS IS REAL. I'M FRUSTRATED WITH EVERYONE. WITH THE HOLIDAYS COMING, WILL HAVE COMPANY FOR 1 WEEK. DREADING THIS. I USUALLY LOOK FORWARD TO IT. EVERYONE THINKS I SHOULD BE OK, BUT I'M NOT! WENT TO FAMILY DOCTOR; NO ANSWER. HAS ANYONE ELSE FELT LIKE THIS? I ALSO HAVE DIVERTICULOSIS, BUT SYMPTOMS ARE DIFFERENT. I PUT POP AS DIAGNOSIS, BUT WAS A TOTAL VAGINAL PROLAPSE; UTERUS WAS OUT. SO HAD MESH FOR BLADDER, RECTOCELE PLUS ALL AFOREMENTIONED. CAN'T STAND PAIN AND BEING TIRED ANYMORE. I'M NOW (B)(6), BUT FEEL OLDER, FATTER, AND LAZY. I USED TO LOVE WORKING IN YARD, SHOPPING, AND CLEANING; NORMAL HOUSEKEEPING. HAD CLEANING LADY AFTER SURGERY, BUT LET HER GO BECAUSE I WANTED TO DO IT MYSELF, BUT IT IS HARD TO KEEP UP. JUST MY HUSBAND AND DOG. OUR CHILDREN ARE GROWN. WE HAVE LARGE HOME AND YARD. JUST WANT AN ANSWER AND TO FEEL NORMAL!! WHAT ELSE CAN I SAY TO GET THIS POSTED. PLEASE, I NEED ANSWERS AND CAN'T GET THEM. IS THIS HOW I AM GOING TO LIVE OR WILL IT GET BETTER. SOME SAY 1 YEAR TO 18 MONTHS FOR FULL RECOVERY, BUT THE DOCTOR SURE DIDN'T SAY THIS; HE NEVER REALLY SAID." }, { "mdr_text_key": "10288258", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. SYSTEM LOGS WERE REVIEWED FOR THE SYSTEM BUT NO SURGERIES WERE LOGGED FOR THE DATE OF THE EVENT ((B)(6) 2012). NO OTHER SYSTEMS COULD BE FOUND FOR THIS PARTICULAR ACCOUNT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED." } ], "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": "" } ] }