{ "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": "2955842-2015-00789", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20150522", "manufacturer_address_2": "", "pma_pmn_number": "", "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": [ "Foreign", "Literature", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150526", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "335688", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150522", "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": "DA", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20150522", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ischemia", "Occlusion", "Injury", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20150423", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4791809", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150616", "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": "5877164", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A BJU INTERNATIONAL JOURNAL ARTICLE TITLED, PERIOPERATIVE AND RENAL FUNCTIONAL OUTCOMES OF ELECTIVE ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN) FOR RENAL TUMOURS WITH HIGH SURGICAL COMPLEXITY (VOLPE ET AL., 2014). THE JOURNAL ARTICLE NOTES SEVERAL OPERATIVE COMPLICATIONS. REFER TO MFR. REPORT 2955842-2015-00706 (PATIENT IDENTIFIER (B)(6)) WHICH WAS INITIALLY SUBMITTED TO THE FDA AND BEFORE THE SITE AND SURGEON NAMES RELATED TO THE SURGICAL PROCEDURES WERE KNOWN. ON (B)(6) 2015, A CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE PROVIDED THE SITE AND SURGEON NAMES OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE. IN THE RESULTS SECTION OF THE BJUI JOURNAL ARTICLE, THE FOLLOWING IS STATED: IN ALL, 44 RAPNS FOR RENAL TUMOURS WITH PADUA SCORES OF > 10 WERE INCLUDED IN THE ANALYSIS; 23 TUMOURS (52.3%) WERE CT1B. THE MEDIAN (INTERQUARTILE RANGE; RANGE) OPERATIVE TIME, ESTIMATED BLOOD LOSS AND WARM ISCHAEMIA (WIT) WERE 120 (94, 132; 60-230) MIN, 150 (80, 200; 25- 1200) ML AND 16 (13.8, 18; 5-35) MIN, RESPECTIVELY. TWO INTRAOPERATIVE COMPLICATIONS OCCURRED (4.5%); ONE INFERIOR VENA CAVAL INJURY AND ONE BLEED FROM THE RENAL BED, WHICH WERE BOTH MANAGED ROBOTICALLY. THERE WERE POSTOPERATIVE COMPLICATIONS IN 10 PATIENTS (22.7%), OF WHOM FOUR (9.1%) WERE HIGH CLAVIEN GRADE, INCLUDING TWO BLEEDS THAT REQUIRED PERCUTANEOUS EMBOLIZATION, ONE URINOMA THAT RESOLVED WITH URETERIC STENTING AND ONE BOWEL OCCLUSION MANAGED WITH LAPAROSCOPIC ADHESIOLYSIS. TWO PATIENTS (4.5%) HAD POSITIVE SURGICAL MARGINS (PSMS) AND WERE FOLLOWED EXPECTANTLY WITH NO RADIOLOGICAL RECURRENCE AT A MEAN FOLLOW-UP OF 23 MONTHS. THE MEAN SERUM CREATININE LEVELS WERE SIGNIFICANTLY INCREASED AFTER SURGERY (121.1 VS 89.3 UMOL/L = 0.001), BUT DECREASED OVER TIME, WITH NO SIGNIFICANT DIFFERENCES FROM THE PREOPERATIVE VALUES AT THE 6-MONTH FOLLOW-UP (96.4 VS 89.3 UMOL/L; P = 0.09). THE SAME TREND WAS SEEN FOR EGFR. THERE IS NO ALLEGATION WITHIN THE ARTICLE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED." }, { "mdr_text_key": "13297169", "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 OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. ISI HAS ATTEMPTED TO CONTACT A CORRESPONDENCE CONTACT OF THE JOURNAL ARTICLE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE JOURNAL ARTICLE INDICATES THAT A PATIENT UNDERWENT A DA VINCI ASSISTED PARTIAL NEPHRECTOMY AND EXPERIENCED A BOWEL OCCLUSION MANAGED WITH LAPAROSCOPIC ADHESIOLYSIS. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S OPERATIVE COMPLICATION IS UNKNOWN. REFER TO THE FOLLOWING PATIENT IDENTIFIERS FOR MDR SUBMISSION OF THE OTHER OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE: PATIENT IDENTIFIER (B)(6) - INFERIOR VENA CAVAL INJURY PATIENT IDENTIFIER (B)(6) - BLEED FROM THE RENAL BED PATIENT IDENTIFIER (B)(6) - BLEED THAT REQUIRED PERCUTANEOUS EMBOLIZATION (1 OF 2 BLEEDS) PATIENT IDENTIFIER (B)(6) - BLEED THAT REQUIRED PERCUTANEOUS EMBOLIZATION (2 OF 2 BLEEDS) PATIENT IDENTIFIER (B)(6) - URINOMA THAT RESOLVED WITH URETERIC STENTING." }, { "mdr_text_key": "13309917", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 06/16/2015 AND 06/25/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM A CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE. THE CORRESPONDENCE CONTACT PROVIDED THE FOLLOWING INFORMATION: IT IS UNKNOWN WHAT DATE THE DA VINCI PARTIAL NEPHRECTOMY PROCEDURE WAS PERFORMED. THE CORRESPONDENCE CONTACT REVIEWED THE PATIENT'S FILE AND COULD NOT VERIFY THE REPORTED OPERATIVE COMPLICATION OF A BOWEL OCCLUSION MANAGED WITH LAPAROSCOPIC ADHESIOLYSIS. THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE COMPLICATIONS. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. THE DA VINCI PARTIAL NEPHRECTOMY PROCEDURE WAS COMPLETED. ACCORDING TO THE CORRESPONDENCE CONTACT, THE PATIENT EXPERIENCED HIGH GASTRO-INTESTINAL BLEEDING ON (B)(6) 2011 AND PASSED AWAY THAT SAME DAY. THE CAUSE OF DEATH IS UNKNOWN. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT A DA VINCI SURGICAL PROCEDURE, EXPERIENCED AN OPERATIVE COMPLICATION, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S OPERATIVE COMPLICATION AND SUBSEQUENT DEMISE ARE UNKNOWN." } ], "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": "06/30/2015" } ] }