{ "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": "2955842-2014-05784", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20141204", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20141022", "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 representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20141204", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "783576", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141204", "brand_name": "DA VINCI SI 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": "IS3000 A6.0P8", "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": "20141204", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20141104", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4298409", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141104", "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": "15814071", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI NEPHRECTOMY PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT SUSTAINED A PERFORATED SMALL BOWEL. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT'S LARGE BOWEL ENDED UP GETTING PUSHED THROUGH THE PERFORATION. FIVE DAYS AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND UNDERWENT AN X-RAY AND CT-SCAN FOR COMPLAINTS OF ABDOMINAL PAIN. ON (B)(6) 2014, THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE TO REPAIR THE BOWEL PERFORATION. THE PATIENT WAS ADMITTED TO THE ICU. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS STILL IN THE HOSPITAL. HE ALSO STATED THAT THERE WERE NO REPORTS FROM THE SITE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM HAD OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. ON (B)(6) 2014, ISI ALSO CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER STATED THAT HE CONFIRMED WITH THE SURGICAL STAFF THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER WAS UNABLE TO PROVIDE A POSSIBLE CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION AND STATED THAT THE SITE IS PERFORMING AN INTERNAL INVESTIGATION REGARDING THE REPORTED EVENT." }, { "mdr_text_key": "15956212", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2010. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A PERFORATED SMALL BOWEL WHILE UNDERGOING A DA VINCI NEPHRECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION IS UNKNOWN. IN ADDITION, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE 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": "" } ] }