{ "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": "2955842-2015-00706", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20150508", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150508", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "302474", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150508", "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": "20250812", "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": "20150508", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Occlusion", "Complaint, Ill-Defined", "Injury" ] } ], "distributor_city": "", "date_report": "20150413", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4759698", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150423", "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": "5783043", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A BJU INTERNATIONAL (BJUI) 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 903-909). THE OBJECTIVE OF THE STUDY WAS TO EVALUATE THE PERIOPERATIVE, POST-OPERATIVE, AND FUNCTIONAL OUTCOMES OF ROBOT-ASSISTED PARTIAL NEPHRECTOMY RAPN FOR RENAL TUMORS WITH HIGH SURGICAL COMPLEXITY AT A LARGE VOLUME CENTER. PER THE ARTICLE, FROM SEPTEMBER 2006 TO DECEMBER 2012, 185 PATIENTS UNDERWENT RAPN WITH THE DA VINCI SURGICAL SYSTEM AT THE CENTER. WITHIN THE ARTICLE, THE FOLLOWING STATEMENT WAS NOTED, TWO INTRAOPERATIVE COMPLICATIONS OCCURRED (4.5%): ONE INFERIOR VENA CAVAL INJURY AND ONE BLEED FROM THE RENAL BED, WHICH WERE BOTH MANAGED ROBOTICALLY. (903). IN ADDITION, THE ARTICLE STATES, 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." }, { "mdr_text_key": "29324482", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ADDITIONAL INFORMATION: ON 04/23/2015, INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION REGARDING THE OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE. A CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE PROVIDED ISI WITH THE SITE AND SURGEON NAMES, AND SURGICAL PROCEDURE DATES RELATED TO THE OPERATIVE COMPLICATIONS. REFER TO THE FOLLOWING PATIENT IDENTIFIERS FOR MDR SUBMISSION OF THE 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 PATIENT IDENTIFIER (B)(6) - BOWEL OCCLUSION MANAGED WITH LAPAROSCOPIC ADHESIOLYSIS BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAINED REPORTABLE DUE TO THE FOLLOWING CONCLUSION: ACCORDING TO THE JOURNAL ARTICLE, A NUMBER OF PATIENTS EXPERIENCED OPERATIVE COMPLICATIONS AS A RESULT OF UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSES OF THE OPERATIVE COMPLICATIONS ARE STILL UNKNOWN." }, { "mdr_text_key": "13441510", "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 COMPLICATIONS EXPERIENCED BY THE PATIENTS. THERE IS NO INDICATION OR CLAIM WITHIN THE ARTICLE THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING ANY OF THE DA VINCI SURGICAL PROCEDURES. ISI HAS ATTEMPTED TO CONTACT THE CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENTS; 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: ACCORDING TO THE JOURNAL ARTICLE, A NUMBER OF PATIENTS EXPERIENCED OPERATIVE COMPLICATIONS AS A RESULT OF UNDERGOING DA VINCI PARTIAL NEPHRECTOMY PROCEDURES. HOWEVER, THE CAUSES OF THE PATIENTS' OPERATIVE COMPLICATIONS 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": "05/22/2015" } ] }