{ "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": "2955842-2014-00361", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20140121", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130204", "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": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140121", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "50414", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140121", "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 A6.0P6", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20140121", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L" ], "patient_age": "86 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Sepsis", "Hernia" ] } ], "distributor_city": "", "date_report": "20131219", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3582938", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140508", "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": "12963838", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT WHO REPORTEDLY UNDERWENT A PARTIAL NEPHRECTOMY FOR RENAL MASS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, SUPPLEMENTAL OPERATIVE REPORTS, AND MEDICAL RECORDS. ACCORDING TO THE OPERATIVE REPORT, ON (B)(6) 2013 THE PATIENT UNDERWENT THE FOLLOWING: LAPAROSCOPIC RENAL EXPLORATION, LEFT LAPAROSCOPIC RENAL ULTRASOUND, ATTEMPTED LEFT LAPAROSCOPIC PARTIAL NEPHRECTOMY, CONVERTED TO LAPAROSCOPIC RADICAL NEPHRECTOMY. THERE WAS NO INDICATION THAT THE DA VINCI SURGICAL SYSTEM WAS USED DURING THE PATIENT'S PARTIAL NEPHRECTOMY PROCEDURE. ALTHOUGH THERE IS A REFERENCE IN THE PHYSICIAN'S ORDERS FOR A LEFT LAPAROSCOPIC ROBOTIC PARTIAL NEPHRECTOMY, THE ACTUAL SURGICAL CONSENT OMITS ANY REFERENCE TO ROBOTIC SURGERY. THE DOCTOR'S OPERATIVE REPORT DOES NOT MENTION USE OF ANY DA VINCI EQUIPMENT, ACCESSORIES, OR INSTRUMENT. THE DA VINCI SURGICAL SYSTEM ITSELF IS COMPLETELY EXCLUDED FROM THE DICTATED OPERATIVE REPORT. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THE PREVIOUSLY SUBMITTED REGULATORY REPORT IS BEING RETRACTED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THERE IS NO INDICATION THAT A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY WAS USED DURING THE PATIENT'S PARTIAL NEPHRECTOMY PROCEDURE. IN ADDITION, THERE IS NO INDICATION THAT A DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE." }, { "mdr_text_key": "11441386", "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 POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ON (B)(6) 2014, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT FROM THE SITE. ACCORDING TO THE RISK MANAGER, THE PATIENT UNDERWENT AN UNRECORDED DA VINCI PARTIAL NEPHRECTOMY PROCEDURE DUE TO A SMALL MASS LOCATED ON THE PATIENT'S LEFT KIDNEY. DURING THE SURGICAL PROCEDURE, THE SURGEON CONSULTED WITH THE PATIENT'S FAMILY AND THE DECISION WAS MADE TO PERFORM A FULL NEPHRECTOMY DUE TO THE SIZE AND LOCATION OF THE MASS THAT WAS FOUND. BASED ON THE OPERATIVE REPORT, THE MASS WAS CENTRALLY LOCATED AND WAS NOTED TO BE BUDDING. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. THERE WAS ALSO NO DOCUMENTATION IN THE OPERATIVE REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT UNDERWENT A WOUND EXPLORATION PROCEDURE ON (B)(6) 2013 TO RULE OUT AN INCISIONAL HERNIA. THE PATIENT'S PORT SITE INCISIONS WERE CHECKED AND FOUND TO BE INTACT. NO HERNIAS WERE FOUND. DURING THE SURGICAL PROCEDURE, THE SURGEON ELECTED TO REFRAIN FROM MANIPULATING THE PATIENT'S BOWEL TO PREVENT POTENTIAL ILEUS. THE RISK MANAGER STATED THAT THERE WAS NO DOCUMENTATION THAT THE DA VINCI SURGICAL SYSTEM WAS USED DURING THE WOUND EXPLORATION PROCEDURE. IN ADDITION, ACCORDING TO THE PATIENT'S MEDICAL RECORDS, ON (B)(6) 2013 THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE SINCE THE PATIENT'S CONDITION HAD WORSENED OVERNIGHT. THE PATIENT'S BOWEL WAS FOUND TO BE VIABLE. THE SURGEON MADE THE DECISION TO CONTINUE OBSERVING THE PATIENT AND TO TREAT THE PATIENT FOR A POSSIBLE BOWEL OBSTRUCTION. THERE WAS NO DOCUMENTATION ON THE OPERATIVE REPORT THAT THE DA VINCI SURGICAL SYSTEM WAS USED DURING THE EXPLORATORY LAPAROTOMY PROCEDURE. ON (B)(6) 2013, THE PATIENT PASSED AWAY AFTER EXPERIENCING CARDIAC ARREST. THE PATIENT WAS UNABLE TO BE RESUSCITATED BY THE SITE. THE PATIENT HAD REPORTEDLY DEVELOPED SEPTIC SHOCK RELATED TO A BOWEL OBSTRUCTION AND HAD ALSO SUSTAINED RENAL FAILURE, ACUTE RESPIRATORY FAILURE, AND ASPIRATION PNEUMONIA. THE RISK MANAGER DID NOT FIND ANY DOCUMENTATION IN THE PATIENT'S MEDICAL RECORDS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING ANY SURGICAL PROCEDURE. THE RISK MANAGER DID NOT FIND AN AUTOPSY REPORT IN THE PATIENT'S MEDICAL RECORDS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS, BECAME SEPTIC, AND EXPIRED. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." }, { "mdr_text_key": "4192221", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI NEPHRECTOMY FOR AN UNKNOWN REASON ON (B)(6) 2013. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. ALLEGATIONS OF PATIENT COMPLICATIONS WERE AS FOLLOWS: THE PATIENT WAS TO HAVE A PARTIAL NEPHRECTOMY, BUT BECAUSE OF COMPLICATIONS WITH THE DA VINCI HIS ENTIRE KIDNEY WAS REMOVED. HE DEVELOPED A HERNIA AND UNDERWENT ANOTHER DA VINCI ASSISTED SURGERY TO REPAIR THE HERNIA, HOWEVER THE ROBOT MALFUNCTIONED AND THE SURGERY WAS UNABLE TO BE COMPLETED. ON YET THE THIRD DAY, THE PATIENT, UNDERWENT ANOTHER DA VINCI SURGERY TO REPAIR THE HERNIA. HE SUFFERED COMPLICATIONS, BECAME SEPTIC AND EXPIRED ON (B)(6) 2013." } ], "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": "02/24/2015" } ] }