{ "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": "2955842-2016-00475", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160701", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20150226", "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": "419619", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Internal Organ Perforation", "Septic Shock", "Vomiting", "Coma", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Internal Organ Perforation", "Septic Shock", "Vomiting", "Coma" ] } ], "distributor_city": "", "date_report": "20160601", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5765102", "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": "48652305", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE FOLLOWING INFORMATION IS UNKNOWN: WHAT HOSPITAL THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED AT AND THE NAME OF THE SURGEON WHO PERFORMED THE 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 HER SMALL INTESTINE WAS PERFORATED WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE. AS A RESULT, THE PATIENT HAS ALLEGEDLY EXPERIENCED SEVERAL POST-OPERATIVE COMPLICATIONS WHICH REQUIRED MEDICAL INTERVENTION. HOWEVER, THE ROOT CAUSES OF THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT ARE UNKNOWN." }, { "mdr_text_key": "48652306", "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, (B)(6) STORY. ACCORDING TO THE INTERNET BLOG, THE PATIENT ALLEGED THAT HER SMALL INTESTINE WAS PERFORATED WHILE UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2015. 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)(6) BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED, THE DOCTOR REPORTEDLY INFORMED HER FAMILY THAT EVERYTHING WENT WELL. THE PATIENT WAS SENT HOME THE SAME DAY. WHILE RESTING AT HOME, THE PATIENT FELT SICK, WAS VOMITING, AND HAD LEAKING AT THE INCISION SITE. THE PATIENT COULD NOT KEEP ANYTHING DOWN AND SHE HAD NO APPETITE. AFTER THE PATIENT'S HUSBAND CALLED THE HOSPITAL, THE PATIENT WAS INSTRUCTED TO RETURN TO THE HOSPITAL. WHEN THE PATIENT RETURNED TO THE HOSPITAL, SHE CLAIMED THAT SHE HAD NO BLOOD PRESSURE AND WAS VERY CLOSE TO DYING. THE PATIENT ALSO ALLEGED THAT SHE WAS SEPTIC. DURING THE HOSPITALIZATION, THE PATIENT INDICATED THAT IT WAS DETERMINED THAT HER SMALL INTESTINE HAD BEEN PERFORATED DURING SURGERY. THE PATIENT REPORTEDLY UNDERWENT NUMEROUS UNSPECIFIED SURGERIES AND HAD INFECTED TISSUE CUT OUT FROM HER BELLY. AT ONE POINT, THE PATIENT WAS REPORTEDLY PLACED IN A MEDICAL INDUCED COMA FOR A 2 WEEK PERIOD. AFTERWARDS, THE PATIENT REMAINED IN THE ICU WITH A BREATHING TUBE FOR A WEEK BEFORE BEING TRANSFERRED TO A REGULAR UNIT WHERE SHE REMAINED FOR AN ADDITIONAL 3 WEEKS. THE PATIENT CLAIMED THAT SHE HAD TO RE-LEARN HOW TO USE HER MOTOR SKILLS INCLUDING WALKING AND REQUIRED PHYSICAL THERAPY. IN ADDITION, THE PATIENT INDICATED THAT SHE WAS TREATED FOR MONTHS WITH ANTIFUNGAL AND ANTIBIOTIC MEDICATIONS." } ], "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": "" } ] }