{ "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": "2955842-2015-01008", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150716", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150611", "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": "20150717", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "463328", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150716", "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": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20150716", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "70 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20150617", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4920125", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150617", "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": "6012127", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT AFTER COMPLETION OF A DA VINCI LEFT PARTIAL NEPHRECTOMY PROCEDURE, THE SURGEON ATTEMPTED TO PERFORM A RIGHT COLECTOMY PROCEDURE VIA TRADITIONAL LAPAROSCOPIC SURGERY. DURING THE SURGICAL PROCEDURE, BLEEDING FROM THE LEFT KIDNEY WAS OBSERVED. THE CASE WAS CONVERTED TO OPEN SURGERY IN ORDER TO REMOVE THE ENTIRE KIDNEY. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, THE PATIENT HAD A PRE-EXISTING LOW INR PRIOR TO UNDERGOING THE SURGICAL PROCEDURES. DURING THE SURGICAL PROCEDURES, THE PATIENT WAS ALSO FOUND TO HAVE UNDIAGNOSED CIRRHOSIS OF THE LIVER. NO MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES WERE REPORTED. AFTER COMPLETING THE LEFT PARTIAL NEPHRECTOMY PROCEDURE WITHOUT ANY COMPLICATIONS, THE DA VINCI PATIENT SIDE CART (PSC) WAS UNDOCKED FROM THE PATIENT. THE PATIENT WAS REPOSITIONED AND THE PSC WAS RE-DOCKED TO THE PATIENT IN ORDER FOR THE SURGEON TO PERFORM THE RIGHT COLECTOMY PROCEDURE USING THE SAME PORTS USED DURING THE LEFT PARTIAL NEPHRECTOMY PROCEDURE. AFTER USING THE DA VINCI SURGICAL SYSTEM FOR APPROXIMATELY 45 MINUTES, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL LAPAROSCOPIC SURGERY. THE SURGEON EXPLAINED THAT HE WAS UNABLE TO GAIN ADEQUATE MOBILIZATION WITH THE DA VINCI SURGICAL SYSTEM DUE TO THE PLACEMENT OF THE PORTS USED DURING THE LEFT PARTIAL NEPHRECTOMY PROCEDURE. DURING THE RIGHT COLECTOMY PROCEDURE, BLEEDING WAS OBSERVED FROM THE LEFT KIDNEY. SINCE THE SURGEON COULD NOT FIND THE EXACT SOURCE OF THE BLEEDING AROUND THE KIDNEY, HE MADE THE DECISION TO REMOVE THE ENTIRE KIDNEY. THE SURGEON THEN CONVERTED THE SURGICAL PROCEDURE TO OPEN SURGERY IN ORDER TO EXTRACT THE KIDNEY. UPON CONVERTING TO OPEN SURGERY, THE SURGEON FOUND A POOL OF BLOOD AROUND THE KIDNEY. AFTER THE KIDNEY WAS REMOVED, NO FURTHER BLEEDING WAS OBSERVED. THE PATIENT DID NOT RECEIVE ANY BLOOD TRANSFUSIONS AND NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. THE CSR COULD NOT RECALL THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURES. ACCORDING TO THE CSR, THE SURGEON ATTRIBUTED THE INTRA-OPERATIVE BLEEDING TO THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS OF HAVING A LOW INR AND CIRRHOSIS OF THE LIVER." }, { "mdr_text_key": "14214150", "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. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT 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 COMPLICATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WHILE UNDERGOING A DA VINCI LEFT PARTIAL NEPHRECTOMY PROCEDURE AND RIGHT COLECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING AROUND HIS LEFT KIDNEY, AND THE LEFT KIDNEY WAS ULTIMATELY REMOVED VIA OPEN SURGERY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE BLEEDING IS UNKNOWN. THERE IS ALSO NO CLAIM THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE COMPLICATION." } ], "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": "" } ] }