{ "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": "2955842-2013-05408", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131122", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120827", "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": "20131125", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "608618", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131122", "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": "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20131122", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " L", " R" ], "patient_age": "67 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Septic Shock" ] } ], "distributor_city": "", "date_report": "20131104", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3484882", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150226", "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": "16217266", "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 PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2012. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT'S URETHRA WAS CUT, ADDITIONAL SURGERY WAS REQUIRED, AND THE PATIENT PASSED AWAY FROM SEPTIC SHOCK ON (B)(6) 2012. INTUITIVE SURGICAL, INC. (ISI) WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY PATIENT MEDICAL RECORDS. BASED ON THE LEGAL DOCUMENT PROVIDED, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "13109790", "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 UNDERWENT A DA VINCI-ASSISTED EXCISION OF SPERMATIC CORD, VAS DEFERENS AND REGIONAL LYMPHADENECTOMY, EN BLOC ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. ACCORDING TO THE DA VINCI OPERATIVE REPORT, FINDINGS INCLUDED GROSSLY NORMAL LYMPH NODES ON INSPECTION, THOUGH CIRCUMFERENTIAL DISSECTION AS WELL AS LYMPH NODE DISSECTION ON THE EXTERNAL ILIAC ARTERY WAS PERFORMED UP TO THE LEVEL OF THE CROSSING OF THE URETER. NO EVIDENCE OF PERSISTENT SPERMATIC CORD AT THE INTERNAL RING AND NO REQUIREMENT FOR CLOSURE OF THE INTERNAL RING ITSELF WAS DEEMED INDICATED. A DISCHARGE SUMMARY WAS NOT AVAILABLE FOR REVIEW. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2012 AND WAS ADMITTED. A CT-SCAN SHOWED A LARGE FLUID COLLECTION IN THE LEFT ABDOMEN. ON (B)(6) 2012, THE PATIENT HAD PERCUTANEOUS DRAIN OF FLUID COLLECTION WITH CREATININE WHICH WAS CONSISTENT WITH URINE. ON (B)(6) 2012, THE PATIENT UNDERWENT A CYSTOURETHROSCOPY AND LEFT RETROGRADE PYELOGRAM. THE POST-OPERATIVE DIAGNOSIS WAS A LEFT ABDOMINAL URINOMA. THE LEFT URETERAL ORIFICE WAS IDENTIFIED AND CANNULATED WITH A 5-FRENCH OPEN-END CATHETER. A RETROGRADE PYELOGRAM WAS PERFORMED. THERE WAS GROSS EXTRAVASATION OF CONTRAST AT THE AREA OF THE LEFT SI JOINT WITHOUT CONTRAST GOING UP THE PROXIMAL URETER. AT THIS POINT, THERE WAS CONCERN OF URETERAL INJURY. THE SURGEON TOOK A 0.035 GLIDEWIRE AND ATTEMPTED TO ADVANCE PROXIMALLY. THE SURGEON NOTED, THIS WOULD GO UP BEYOND THE AREA OF EXTRAVASATION, BUT WOULD NOT GO IN A PATH CONSISTENT WITH THE PROXIMAL URETER. THE SURGEON TOOK AN ANGLE-TIP GLIDEWIRE BUT WAS UNABLE TO GO UP TO THE AREA OF THE RENAL PELVIS. THE SURGEON DISCUSSED THE CASE WITH ANOTHER PHYSICIAN AND THE DECISION WAS MADE TO TERMINATE THE PROCEDURE. THE SURGEON NOTED, THE POSTERIOR URETHRA REVEALED TRILOBAR OBSTRUCTION. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT CONTINUED TO DECLINE RAPIDLY, REQUIRING EMERGENT INTUBATION. THE PATIENT WAS PLACED IN AN ICU FOR HEMODYNAMIC MONITORING. THE PATIENT WAS ULTIMATELY DIAGNOSED WITH SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, SEPTICEMIA, ACUTE RENAL FAILURE, AND ACUTE RESPIRATORY FAILURE. THE CASE WAS COMPLICATED BY MULTIPLE CONFOUNDING COMORBID CONDITIONS. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY ON (B)(6) 2012 WHERE HE FROM SUFFERED ACUTE RESPIRATORY FAILURE AND SEPTIC SHOCK. THE PATIENT EXPIRED ON (B)(6) 2012. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE IS UNKNOWN." }, { "mdr_text_key": "16578307", "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 AND POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT, AND HIS SUBSEQUENT DEMISE. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ON (B)(4) 2013, ISI CONTACTED THE RISK MANAGER FROM THE SITE. THE RISK MANAGER STATED THAT SHE COULD NOT PROVIDE ANY INFORMATION REGARDING THE REPORTED EVENT DUE TO PATIENT CONFIDENTIALITY AND SINCE THE EVENT IS A LEGAL CASE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT REPORTEDLY SUSTAINED A URETHRAL INJURY WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE, HAD ADDITIONAL SURGERY PERFORMED, AND SUBSEQUENTLY PASSED AWAY AFTER DEVELOPING SEPTIC SHOCK. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S URETHRAL INJURY AND SEPTIC SHOCK IS 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": "03/26/2015" } ] }