{ "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": "2955842-2014-03962", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140627", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140630", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "377712", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140627", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC ELECTROSURGICAL 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": "LAY USER/PATIENT", "model_number": "", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20140627", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Hematuria", "No Code Available" ] } ], "distributor_city": "", "date_report": "20140530", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3900691", "removal_correction_number": "", "number_devices_in_event": "", "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": "11926193", "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 16 PERIOPERATIVE COMPLICATIONS DURING A ROBOTIC -ASSISTED PARTIAL NEPHRECTOMY PROCEDURE. IN THIS ARTICLE THERE WERE PROCEDURE DATES, SURGEON NAME(S) OR HOSPITAL NAME(S) PROVIDED. THE JOURNAL ARTICLE DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED IN THE REPORTED PROCEDURES. ISI HAS ATTEMPTED TO CONTACT THE PRIMARY REPORTER OF THIS COMPLAINT 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: THE JOURNAL ARTICLE INDICATED THAT THERE WERE 16 PERIOPERATIVE COMPLICATIONS THAT DURING A ROBOTIC -ASSISTED PARTIAL NEPHRECTOMY PROCEDURES." }, { "mdr_text_key": "4429008", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON MAY 30, 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A JOURNAL ARTICLE TITLED,THE NEPHROMETRY SCORE: IS IT EFFECTIVE FOR PREDICTING PERIOPERATIVE OUTCOME DURING ROBOT-ASSISTED PARTIAL NEPHRECTOMY? THIS ARTICLE IS FROM KOREAN JOURNAL OF UROLOGY, PUBLISHED IN 2014. ACCORDING TO THE REPORTED ARTICLE, PERIOPERATIVE COMPLICATIONS OCCURRED IN 16 PATIENTS, INCLUDING 6 PERIRENAL ORGAN INJURIES, 2 OPEN CONVERSIONS, 3 WOUND COMPLICATIONS, AND 3 GROSS HEMATURIA CASES. ORGAN INJURY CASES CONSISTED OF TWO RENAL VEIN LACERATIONS, TWO SPLEEN INJURIES, AND ONE LIVER AND COLON INJURY. TWO OPEN CONVERSIONS WERE DETERMINED OWING TO DIFFICULTY IN APPROACHING THE ISOLATED RENAL TUMOR AND A TOO SMALL PERITONEAL CAVITY FOR ROBOT CONTROL, RESPECTIVELY. POSTOPERATIVELY, THERE WERE THREE HEMATURIA AND TRANSFUSION CASES, ONE WOUND PROBLEM, ONE ILEUS, AND ONE MINOR PROBLEM RANKED AS CLAVIEN GRADE I OR II. THE MAJOR POSTOPERATIVE COMPLICATIONS CLASSIFIED AS CLAVIEN GRADE III WERE TWO OTHER WOUND PROBLEMS THAT NEEDED REPAIRING AND ONE CASE OF ABDOMINAL FLUID COLLECTION THAT REQUIRED PERCUTANEOUS DRAINAGE. UNIVARIATE AND MULTIVARIATE ANALYSES REVEALED THAT NO PARAMETER HAD A SIGNIFICANT CORRELATION WITH PERIOPERATIVE COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENTS. THE DA VINCI SERIAL NUMBER(S) INVOLVED WITH ALL 16 PATIENTS WERE NOT INCLUDED IN THIS ARTICLE." } ], "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": "" } ] }