{ "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": "2955842-2012-00702", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20121027", "manufacturer_address_2": "", "pma_pmn_number": "K063220", "date_of_event": "20120831", "reprocessed_and_reused_flag": "", "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": "20121031", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20121027", "brand_name": "DA VINCI S SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC ELECTROSURGICAL 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": "0", "model_number": "IS3000 A5.1P8", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20121027", "sequence_number_treatment": [ "DAVINCI S SUG. SYS., INSTRUMENTS, & ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "32 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Injury" ] } ], "distributor_city": "", "date_report": "20120926", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2807222", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120926", "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": "2948576", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, A PATIENT POSTED THE FOLLOWING INFORMATION ON (B)(4): MY DOCTOR RECOMMENDED THE DA VINCI FOR MY HYSTERECTOMY. I AM ONLY (B)(6) BUT, ALSO NEEDED TO HAVE MY OVARIES REMOVED. I WENT IN FOR THE SURGERY AND CAME OUT ABOUT THREE HOURS LATER TO FIND OUT THAT THE DOCTOR HAD MISSED MY UTERUS AND HIT MY RECTUM. CONSIDERED A MISTAKE. SO, NOW I HAVE TO HAVE ANOTHER SURGERY ON (B)(6)2012, AND THEY WILL BE REOPENING MY C-SECTION SCAR. I THINK THE DA VINCI IS THE WORSE THING OUT THERE PEOPLE! THE DOCTORS JUST LIKE TO USE IT BECAUSE, IT IS A COOL NEW TOY FOR THEM! I AM HOPING NOW THAT THERE IS NOT TO MUCH DAMAGE FROM THE DA VINCI. I HAVE SCARS THAT I DIDN'T NEED TO HAVE AND HAD A SURGERY THAT I DIDN'T NEED TO HAVE! I WOULD NOT RECOMMEND ANYONE TO GET THE DA VINCI. I HAVE HAD A TON OF PAIN AND BECAUSE OF IT, I HAVE TO HAVE ANOTHER SURGERY! I HAVE TWO SMALL CHILDREN AND TRUSTED THAT MY DOCTOR KNEW WHAT HE WAS DOING BUT, THAT WAS COMPLETELY WRONG! SURGEONS SHOULD NOT TELL YOU THAT IT IS GOING TO BE OK AND THAT THIS IS A GREAT NEW TOOL BECAUSE, IT DOESN'T WORK AT ALL! I HAD TO HAVE ANOTHER GENERAL SURGEON COME AND CHECK TO MAKE SURE THE DA VINCI DID NOT DO A TON OF DAMAGE! DOCTORS SHOULD BE EDUCATED MORE ON USING MACHINES TO OPERATE WITH. WE ARE NOT PRACTICE DOLLS! MY DOCTOR FINALLY ADMITTED THAT I WAS ONLY TENTH PERSON HE HAD DONE THIS ON. I AM NOT HAPPY ABOUT THAT! THERE NEEDS TO BE A BETTER PAPER OUT THERE EXPLAINING WHAT COULD END UP HAPPENING IF SURGERY GOES WRONG! I ONLY RECEIVED A PAMPHLET ON HOW GREAT THIS MACHINE WAS AND IT TURNED OUT TO RUIN MY LIFE!" }, { "mdr_text_key": "10252512", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR), AS HE WAS PRESENT DURING THE PROCEDURE. ACCORDING TO THE INFORMATION PROVIDED BY THE CSR, THE EVENT OCCURRED WHEN THE UTERINE MANIPULATOR, AN INSTRUMENT NOT SOLD BY INTUITIVE SURGICAL, WAS PLACED BY THE PHYSICIAN, THE TIP OF THE RUMI PERFORATED THE CERVIX. PHYSICIAN HAD PLACED THE PORTS INTO THE PATIENT'S ABDOMEN TO CREATE THE PORT INCISIONS, BUT THE SURGEON MADE THE DECISION TO ABORT THE PROCEDURE ONCE HE REALIZED THAT THE UTERINE MANIPULATOR WAS MISPLACED. THE PATIENT WAS BROUGHT BACK AT LATER DATE FOR A TAH (TOTAL ABDOMINAL HYSTERECTOMY) DUE TO THE PATIENT'S ANATOMY. ACCORDING TO THE INFORMATION PROVIDED TO THE CSR, THE PATIENT WAS RELEASED FROM THE HOSPITAL. BASED ON THE INFORMATION PROVIDED BY THE CSR, NO SYSTEM MALFUNCTION OCCURRED WITH THE DA VINCI S SYSTEM, INSTRUMENTS AND/OR ACCESSORIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S COMPLICATIONS." } ], "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": "" } ] }