{ "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": "2955842-2013-05193", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131114", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20111204", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "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": "20131114", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "590000", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131114", "brand_name": "DA VINCI 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": "", "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": [ "Improper or Incorrect Procedure or Method", "Device Operates Differently Than Expected" ], "reporter_state_code": "MD", "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": "20131114", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Internal Organ Perforation" ] } ], "distributor_city": "", "date_report": "20131105", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3469772", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131105", "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": "3938566", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL, INC. RECEIVED A VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING DESCRIPTION: I WAS NEEDING SURGERY FOR MINOR COLON CANCER. I WAS PLANNING ON RETURNING TO WORK WITHIN 5 WEEKS. MY DOCTOR AT XX HOSPITAL INSISTED THAT I DO ROBOTIC SURGERY. ALL THE PROS AND CONS WERE STATED FOR ME. AFTER SURGERY, I HAD A LARGE HOLE IN MY VAGINA. MORE SURGERY WAS DONE TO TRY TO REPAIR DAMAGE. IT WAS UNSUCCESSFUL. I ENDED UP WITH AN ILEOSTOMY FOR MONTHS, WAITING FOR VAGINA TO HEAL. MY BLADDER WAS DAMAGED AND HAS NEVER WORKED. NOW I USE CATHS. I WAS TOLD THAT MY BLADDER WAS BADLY BEATEN UP WITH ROBOTIC SURGERY. IT WAS 6 MONTHS BEFORE I COULD WORK. I SWITCHED HOSPITALS. AT XX HOSPITAL, I WAS TOLD BY DOCTORS THAT COLON SURGERY FOR FEMALES SHOULD NEVER BE DONE BY ROBOTICS. I RECENTLY SAW A REPORT ON NBC AND REALIZED THAT I AM NOT THE ONLY ONE MESSED UP FOR LIFE BECAUSE OF THIS ROBOTIC SURGERY. PLEASE STOP THE DOCTORS AND HOSPITALS FROM \"PUSHING\" THIS SURGERY. I WAS THE EXPERIMENTAL RATE OF THE DAY. IT CLEARLY SUCKS. I WAS TOLD BY A LAWYER THAT IF I PURSUED A LAWSUIT THAT THERE WAS NO WINNING AGAINST A BIG CORPORATION LIKE THE MEDICAL FIELD. PATIENT AND HOSPITAL INFORMATION NAMES WERE NOT PROVIDED WITH THE VOLUNTARY REPORT; THEREFORE, ISI IS UNABLE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT AT THIS TIME." }, { "mdr_text_key": "11318179", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI 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": "" } ] }