{ "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": "Death", "report_number": "2955842-2013-01547", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130503", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130325", "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": "20130506", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "193663", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130503", "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 A60.P7", "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": "AL", "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": "20130503", "sequence_number_treatment": [ "DA VINCI SI SURG SYST., INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20130405", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3092988", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130405", "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": "10687838", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, ISI CONTACTED THE CSR WHO INITIALLY REPORTED THIS EVENT. THE CSR INDICATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE. PER THE CSR THE PATIENT HAD SIGNIFICANT ADHESIONS AS A RESULT OF A PREVIOUS OPEN SURGICAL PROCEDURE AND THAT THE PATIENT'S ADHESIONS WERE TAKEN DOWN USING TRADITIONAL LAPAROSCOPIC TECHNIQUES. THE SURGEON USED A 12MM EXCEL ETHICON BLADELESS TROCAR TO CREATE THE UMBILICUS PORT SITE. THE CSR INDICATED THAT THERE WAS NO MALFUNCTION OF THE SITE'S DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND OR ACCESSORIES DURING THE ROBOTIC PORTION OF THE SURGICAL PROCEDURE AND THE ROBOTIC PROCEDURE WAS SUCCESSFULLY COMPLETED. THE CSR INDICATED THAT THE SURGEON REPORTED TO HIM THAT 36 HOURS POST-OP THE PATIENT PRESENTED SYMPTOMS OF FEVER AND SEPSIS. AN EMERGENCY LAPAROTOMY PROCEDURE PERFORMED ON THE PATIENT REVEALED THAT THE PATIENT'S COLON HAD A HOLE. PER THE CSR, THE SURGEON TOLD HIM THAT THE SIZE OF THE HOLE WAS THE SAME SIZE AS THE TROCAR THAT WAS USED DURING CREATION OF THE PATIENT'S UMBILICUS PORT SITE. THE CSR INDICATED THAT THE SURGEON BELIEVES THAT DAMAGE TO THE PATIENT'S COLON OCCURRED DURING CREATION OF THE UMBILICUS PORT SITE. THE DATE OF THE PATIENT'S DEMISE IS UNKNOWN. ISI HAS CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI SURGICAL SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE, BUT LIKELY OCCURRED AS A RESULT OF THE INJURY SUSTAINED BY THE PATIENT DURING CREATION OF THE PATIENT'S UMBILICUS PORT SITE BY THE SURGEON WHILE UTILIZING A ETHICON BLADELESS TROCAR. ISI HAS NOTIFIED THE MANUFACTURER OF THE TROCAR REGARDING THIS REPORT." }, { "mdr_text_key": "3290108", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. REPORTEDLY 36 HOURS AFTER SUCCESSFUL COMPLETION OF THE SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S BOWEL WAS PUNCTURED. IT WAS REPORTED THAT THE PATIENT EXPIRED." } ], "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": "" } ] }