{ "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": "2955842-2016-00474", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160701", "manufacturer_address_2": "", "pma_pmn_number": "", "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": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160701", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "420411", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160701", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20160701", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Diarrhea", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Nausea", "Nerve Damage", "Pain", "Swelling", "Tinnitus", "Blurred Vision", "Chills", "Dizziness", "Urinary Frequency / Polyuria", "Anxiety", "Alteration In Body Temperature", "Abdominal Pain", "Diarrhea", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Nausea", "Nerve Damage", "Pain", "Swelling", "Tinnitus", "Blurred Vision", "Chills", "Dizziness", "Urinary Frequency / Polyuria", "Anxiety", "Alteration In Body Temperature" ] } ], "distributor_city": "", "date_report": "20160601", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5765087", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160601", "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": "48653767", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE FOLLOWING INFORMATION IS UNKNOWN: THE SPECIFIC DATE THAT THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED, WHAT HOSPITAL THE SURGICAL PROCEDURE WAS PERFORMED AT, AND THE NAME OF THE SURGEON WHO PERFORMED THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE PATIENT'S FULL NAME AND CONTACT INFORMATION ARE ALSO UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE SURGEON INJURED NERVES TO HER BLADDER AND COLON WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE. AS A RESULT, THE PATIENT HAS ALLEGEDLY EXPERIENCED SEVERAL POST-OPERATIVE COMPLICATIONS. HOWEVER, THE ROOT CAUSE OF THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT IS UNKNOWN." }, { "mdr_text_key": "48653768", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 06/01/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE UNPLUG THE ROBOT INTERNET BLOG TITLED, TINA'S STORY. ACCORDING TO THE INTERNET BLOG, THE PATIENT INDICATED THAT SHE UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE AND CLAIMED THAT THE SURGEON DAMAGED NERVES IN HER BLADDER AND POSSIBLY INTESTINES. AS A RESULT, THE PATIENT ALSO CLAIMED THAT SHE HAS EXPERIENCED NUMEROUS POST-OPERATIVE COMPLICATIONS. THE INTERNET BLOG DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE OPERATIVE COMPLICATIONS. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: (B)(4). BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: AFTER CONSULTING WITH HER SURGEON, THE PATIENT MADE THE DECISION TO UNDERGO A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE IN (B)(6) 2014. ACCORDING TO THE PATIENT, SHE EXPERIENCED A LOT OF PAIN WHILE IN THE RECOVERY ROOM AND WAS TREATED WITH AN UNSPECIFIED PAIN PILL. THE PATIENT ALSO MENTIONED THAT SHE STARTED BLEEDING AND HAVING MORE PAIN. THE PATIENT WAS REPORTEDLY GIVEN A PAD AND INFORMED THAT SHE WOULD BE FINE. THE PATIENT WAS DISCHARGED HOME AT 5:00 PM THE SAME DAY. WHEN THE PATIENT GOT HOME, SHE REPORTEDLY HAD NAUSEA, DIARRHEA, DIFFICULTY URINATING, AND BLOOD IN HER URINE. TWO DAYS LATER, THE PATIENT WOKE UP WITH CHILLS AND A TEMPERATURE OF 103 DEGREES. THE PATIENT WAS TAKEN TO AN ER WHERE A CT SCAN, URINALYSIS, AND BLOOD WORK WERE PERFORMED. THE PATIENT WAS FOUND TO HAVE AN INFECTION ON HER VAGINAL CUFF AND BLOOD IN HER URINE. THE PATIENT WAS ADMITTED FOR 3 DAYS AND TREATED WITH IV ANTIBIOTICS. UPON DISCHARGE, THE PATIENT HAD PAIN, DIARRHEA, NAUSEA, FREQUENT URINATION, AND SWOLLEN HANDS. THE PATIENT CLAIMS THAT SHE HAS EXPERIENCED THE FOLLOWING POST-OPERATIVE COMPLICATIONS: CHRONIC ABDOMINAL, PELVIC, AND BACK PAIN, VAGINAL PAIN, CHRONIC VAGINAL INFECTIONS, DIARRHEA, NAUSEA, PANIC ATTACKS, BLURRED VISION, DIZZINESS, LOSS OF BALANCE, RINGING IN HER EARS, AND UNCOORDINATION. FOR A 4 MONTH PERIOD, THE PATIENT COMPLAINED OF HAVING SEVERE GAS PAINS. ON AN UNSPECIFIED DATE, THE PATIENT CONSULTED WITH ANOTHER PHYSICIAN AND WAS REPORTEDLY INFORMED THAT SHE WAS RETAINING URINE AND MOST LIKELY HAD BLADDER NERVE DAMAGE. THE PATIENT ALSO INDICATED THAT A GASTROENTEROLOGIST BELIEVES SHE SUSTAINED NERVE DAMAGE TO HER COLON." } ], "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": "" } ] }