{ "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": "2955842-2013-03248", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130828", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130410", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130828", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "422379", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130828", "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": "MN", "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": "20130828", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRMNTS, ACCESSORIES & ESU." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "44 YR", "patient_sex": "", "patient_weight": "68", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Pain" ] } ], "distributor_city": "", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3314289", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "21030729", "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": "3953868", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4) FROM THE HOSPITAL. THE EVENT DETAILS ARE PROVIDED BELOW: PLEASE NOTE THE 5 CASES BEING REPORTED CONCURRENTLY BY OUR FACILITY HAVE THE D VINCI ROBOT AS A COMMONALITY; WE ARE NOT IMPLYING THAT IT IS THE CAUSE. OUR FACILITY HAS TWO D VINCI ROBOTS. WE ARE UNCERTAIN WHICH OF THE TWO WAS USED IN THIS CASE. ON (B)(6) 2013 THE PATIENT UNDERWENT D¿VINCI PELVISCOPY WITH EXCISION OF ENDOMETRIOSIS. DURING PROCEDURE, IT WAS NOTICED THAT PATIENT HAD ADHESIONS, SO SURGEON WAS CALLED IN TO DO LYSIS OF ABDOMINAL PELVIC ADHESIONS. THE PATIENT WAS DISCHARGED TO HOME (B)(6) 2013. ON (B)(6) 2013, PATIENT WAS READMITTED WITH ABDOMINAL PAIN. CT OF ABDOMEN AND PELVIS FAIRLY UNREMARKABLE. THE PATIENT WAS OBSERVED IN THE HOSPITAL. WITH NO FEVERS, WELL-CONTROLLED PAIN, ABDOMEN WOUND CLEAN AND DRY. PATIENT WAS DISCHARGED ON (B)(6) 2013. THE PATIENT WAS READMITTED THE SAME DAY (B)(6) 2013. THE PATIENT UNDERWENT AN OPEN LAPAROSCOPIC EXPLORATION WITH REPAIR OF SIGMOID COLON PERFORATION. PATIENT WAS DISCHARGED ON (B)(6) 2013." }, { "mdr_text_key": "10918601", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE SITE'S UF/IMPORTER REPORT DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ISI HAS CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO GATHER ADDITIONAL INFORMATION; HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BOWEL INJURY DURING A DA VINCI SI GYNECOLOGICAL 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": "" } ] }