{ "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": "2955842-2016-00477", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "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": "418920", "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": "20250813", "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", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fever", "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Muscle Spasm(s)", "Pain", "Sepsis", "Urinary Tract Infection", "Constipation", "Fever", "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Muscle Spasm(s)", "Pain", "Sepsis", "Urinary Tract Infection", "Constipation" ] } ], "distributor_city": "", "date_report": "20160602", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5765148", "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": "48673465", "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. THE FOLLOWING INFORMATION IS UNKNOWN: WHAT SPECIFIC DATE THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED, WHAT HOSPITAL THE SURGICAL PROCEDURE WAS PERFORMED, AND THE NAME OF THE SURGEON WHO PERFORMED THE DA VINCI-ASSISTED SURGICAL PROCEDURE. IN ADDITION, SPECIFIC DETAILS REGARDING THE ALLEGED ARCING EVENT ARE UNKNOWN. 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 SHE EXPERIENCED POST-OPERATIVE COMPLICATIONS AND REQUIRED MEDICAL INTERVENTION AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE. HOWEVER, THE ROOT CAUSES OF THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT ARE UNKNOWN." }, { "mdr_text_key": "48673466", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE UNPLUG THE ROBOT INTERNET BLOG TITLED, (B)(6) STORY. ACCORDING TO THE INTERNET BLOG, THE PATIENT ALLEGED THAT SHE EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN (B)(6) 2014. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: (B)(6). BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED, THE PATIENT WENT HOME THE SAME DAY. POST-OPERATIVELY, THE PATIENT EXPERIENCED HORRIFIC PAIN ON POST-OP DAY 5 AND FELT AS THOUGH SHE WAS SEVERELY CONSTIPATED. SHE REPORTEDLY HAD A SMALL FEVER AND VISITED HER PHYSICIAN. THE PATIENT INDICATED THAT THE PHYSICIAN THOUGHT SHE HAD A URINARY TRACT INFECTION (UTI) AND WAS PRESCRIBED AN UNSPECIFIED ANTIBIOTIC. THE FOLLOWING DAY, THE PATIENT REPORTEDLY COULDN'T MOVE AND WAS RUSHED TO AN ER WHERE A CAT-SCAN WAS PERFORMED. THE PATIENT WAS FOUND TO HAVE A VAGINAL CUFF HEMATOMA, INTERNAL BLEEDING, AND SEPSIS. THE PATIENT CLAIMED THAT HER BLOOD PRESSURE WAS 40/45 AND SHE WAS TEN MINUTES FROM DEATH. THE PATIENT ALLEGED THAT ARCHING [SIC] FROM THE ROBOT NICKED A BLOOD VESSEL AND CREATED THE INTERNAL BLEEDING. THE PATIENT REPORTEDLY SPENT A WEEK IN THE HOSPITAL AND WAS TREATED BY AN INFECTIOUS DISEASE PHYSICIAN. THE PATIENT INDICATED THAT SHE WAS SENT HOME WITH 4 TYPES OF ANTIBIOTICS AND ULTIMATELY DEVELOPED C-DIFF. THE PATIENT ALSO ALLEGED THAT SHE CURRENTLY EXPERIENCES NON-STOP BLADDER SPASMS." } ], "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": "" } ] }