{ "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": "2955842-2016-00476", "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": "419206", "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": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Low Blood Pressure/ Hypotension", "Pain", "Perforation", "Low Blood Pressure/ Hypotension", "Pain", "Perforation" ] } ], "distributor_city": "", "date_report": "20160602", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5765074", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160602", "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": "48647674", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSES OF THE PATIENT'S 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: WHAT HOSPITAL THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED AT, THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE, AND WHAT SPECIFIC DATE THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED. 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 HER BOWEL WAS NICKED WHILE UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY. AS A RESULT, THE PATIENT HAS ALLEGEDLY EXPERIENCED POST-OPERATIVE COMPLICATIONS. HOWEVER, THE ROOT CAUSES OF THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT ARE UNKNOWN." }, { "mdr_text_key": "48647675", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 06/02/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE (B)(4) INTERNET BLOG TITLED, (B)(4). ACCORDING TO THE INTERNET BLOG, THE PATIENT ALLEGED THAT SHE EXPERIENCED MULTIPLE POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN (B)(6) 2014. 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: THE PATIENT INDICATED THAT THE SURGEON INFORMED HER THAT SHE HAD NICKED THE OUTER LAYER OF THE BOWEL. HOWEVER, THE SURGEON REPORTEDLY DENIED THAT SHE HAD PUNCTURED THE PATIENT'S BOWEL. THE PATIENT CLAIMED THAT SHE WAS INFORMED THAT THE SURGICAL PROCEDURE WOULD LAST 2-3 HOURS. HOWEVER, ACCORDING TO THE PATIENT, THE DA VINCI-ASSISTED SURGICAL PROCEDURE TOOK ALMOST 6 HOURS. DURING THE MIDDLE OF THE NIGHT, THE PATIENT INDICATED THAT HER BLOOD PRESSURE DROPPED DANGEROUSLY AND SHE WAS GIVEN LOTS OF MEDICATION TO RAISE HER BLOOD PRESSURE. DUE TO HER BLOOD PRESSURE BEING SO LOW, THE PATIENT CLAIMED THAT SHE WAS NOT ALLOWED TO TAKE PAIN MEDICATIONS FOR A CERTAIN PERIOD OF TIME. THE PATIENT ALSO CLAIMED THAT HER SURGEON ADMITTED THAT HER BLOOD PRESSURE HAD DROPPED DURING THE SURGICAL PROCEDURE. HOWEVER, THE SURGEON REPORTEDLY INDICATED THAT HER BLOOD PRESSURE HAD NORMALIZED. ON POST-OPERATIVE DAY 4, THE PATIENT WAS DISCHARGED HOME. POST-OPERATIVELY, THE PATIENT INDICATED THAT SHE EXPERIENCED PAIN TO THE POINT THAT SHE REQUIRED ASSISTANCE FROM HER HUSBAND TO SIT, STAND, WALK, AND USE THE BATHROOM." } ], "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": "" } ] }