{ "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": "2955842-2014-03489", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20140606", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20110818", "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": "20140609", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "332047", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140606", "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": "MO", "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": "20140606", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Injury" ] } ], "distributor_city": "", "date_report": "20140416", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3854584", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150529", "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": "17490660", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI RIGHT PARTIAL NEPHRECTOMY FOR A RIGHT UPPER POLE RENAL MASS ON (B)(6) 2011. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. OPERATIVE FINDINGS INCLUDED A RIGHT POLE RENAL MASS CONSISTENT WITH RENAL CELL CARCINOMA. NO EVIDENCE OF LYMPHADENOPATHY WAS NOTED. THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 400-500 ML. ON POST-OPERATIVE DAY (POD) 1, THE PATIENT'S HCT WAS 31. SHE HAD BEEN COMPLAINING OF ABDOMINAL PAIN CONSISTENT WITH INCISIONAL PAIN WHICH WAS BEING CONTROLLED WITH PAIN MEDICATIONS. HER JACKSON-PRATT DRAIN OUTPUT WAS 200 ML OF NON-BRIGHT RED BLOOD WHICH WAS NOTED TO BE TAPERING OFF AT THE END OF A 24-HOUR PERIOD. BY THE AFTERNOON, THE PATIENT BECAME HYPOTENSIVE AND LETHARGIC. HER URINE OUTPUT DECREASED AND APPEARED DARK. HER CREATININE HAD ALSO INCREASED FROM 1.1 TO 3.1. THE PATIENT WAS TRANSFERRED TO ICU AND WAS INTUBATED. AN NG TUBE WAS PLACED. THE PATIENT WAS DIAGNOSED WITH RHABDOMYOLYSIS. OVER THE NEXT FEW DAYS, THE PATIENT BECAME ANURIC. ON (B)(6) 2011 A RETROPERITONEAL ULTRASOUND WITH DUPLEX SCAN WAS PERFORMED AND FOUND TO BE CONSISTENT WITH PERFUSION RESTRICTION. ON POD 3 OR 4, CELLULITIS OF THE RIGHT LOWER QUADRANT WAS NOTED. INFECTIOUS DISEASE WAS CONSULTED AND ANTIBIOTICS WERE GIVEN. ON POD 4 OR 5, THE PATIENT'S CREATININE WAS UP TO 6.9. THE PATIENT REQUIRED MULTIPLE DAYS OF HEMODIALYSIS. THE PATIENT'S HEMOGLOBIN AND HEMATOCRIT WOULD FALL WITH DIALYSIS. THE PATIENT RECEIVED A TOTAL OF 9 UNITS OF PACKED RED BLOOD CELLS (PRBC) FROM POD 3 TO POD 9. HER WHITE BLOOD CELL COUNT HAD INCREASED TO 23. ON (B)(6) 2011, A CT-SCAN REVEALED A LARGE LEFT ABDOMINAL HEMATOMA. ON POD 9, THE CELLULITIS HAD INCREASED SIGNIFICANTLY. THE SURGEON OPENED ONE OF THE RIGHT FLANK PORTS THAT WAS OOZING SMALL AMOUNTS OF SEROUS FLUID. A MILD AMOUNT OF PURULENT DRAINAGE WAS EXPRESSED AND A CULTURE WAS TAKEN. NO EVIDENCE OF A DEFECT WAS FOUND IN THE FASCIA AND THERE WAS NO POCKET OF PUS. THAT SAME DAY, THE PATIENT'S WBC COUNT WAS DOWN TO 17. AT APPROXIMATELY 2:30 PM, ACUTE RED BLOOD VIA THE NG TUBE WAS OBSERVED. APPROXIMATELY 300 ML IN VOLUME WAS NOTED. THE PATIENT WENT INTO ARRHYTHMIA AND A CODE WAS STARTED. THE PATIENT RECEIVED MASSIVE AMOUNTS OF BLOOD TRANSFUSIONS, BICARBONATE, RESUSCITATIVE FLUIDS, AND MEDICATIONS. CHEST COMPRESSIONS WERE REQUIRED TO KEEP CIRCULATION GOING FOR APPROXIMATELY 2-2.5 HOURS UNTIL SHE WAS STABLE FOR TRANSPORT TO THE OR. THE ABDOMEN BECAME ACUTELY DISTENDED DURING CPR. IT WAS FELT THAT THE ACUTE ONSET OF BLEEDING WAS DUE TO THE CHEST COMPRESSIONS, AND WAS LIKELY IN THE LIVER AREA OR PANCREAS, OR STOMACH DUE TO AN ULCER. THE PATIENT HAD BEEN GUAIAC POSITIVE ON NG TUBE PRIOR. IT WAS NOTED THAT THERE WAS POSSIBLE ACUTE ULCER DEVELOPMENT. THAT SAME DAY, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY. AN EXTENSIVE AMOUNT OF BLOOD WAS RELEASED. NO BLEEDING WAS NOTED FROM THE PREVIOUS PARTIAL NEPHRECTOMY. THERE WAS CONCERN FOR BLEEDING FROM THE RENAL HILUM. A VASCULAR CLAMP WAS USED TO CLAMP THE RENAL HILUM. DUE TO A SHORT VEIN, THE SURGEON TRIED TO GET AS CLOSE TO THE VENA CAVA AS POSSIBLE. USING AN ENDO-GIA STAPLER, THE HILUM WAS STAPLED REMOVING THE KIDNEY. THE KIDNEY WAS REMOVED TO EXPLORE BENEATH AND MEDIAL TOWARD THE VENA CAVA. AT THE TIME OF KIDNEY REMOVAL, THE ASSISTANT SURGEON LOCATED BLEEDING EITHER IN THE PANCREAS OR SOFT TISSUE SURROUNDING THE PANCREAS AND VENA CAVA. CHEST COMPRESSIONS CONTINUED. THE PATIENT WAS IN FULL ARREST. TRAUMA SURGERY WAS CONSULTED. A 3 MM HOLE IN THE VENA CAVA WAS FOUND AND OVERSEWN. A SECOND HOLE WAS ALSO IDENTIFIED AND OVERSEWN. TWO BLEEDING AREAS FROM SOFT TISSUE PEDICLES WERE CLAMPED AND SUTURED. NO FURTHER BLEEDING WAS FOUND EXCEPT FOR DIFFUSE OOZING FROM ALL BLEEDING EDGES. THE BOWEL APPEARED ISCHEMIC AT THIS POINT. CPR HAD BEEN ONGOING SINCE 2:30 PM. CPR WAS BRIEFLY HELD. NO ELECTRICAL ACTIVITY IN THE HEART WAS OBSERVED. THE SURGEON MADE THE DECISION TO TERMINATE CPR AT APPROXIMATELY 6:30 PM. PER THE DEATH CERTIFICATE, THE IMMEDIATE CAUSE OF DEATH WAS A) HEMORRHAGE (NON-TRAUMATIC); B) POST-OPERATIVE, AND C) REMOVAL OF RENAL MASS. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS THAT LEAD TO HER DEATH ARE UNKNOWN." }, { "mdr_text_key": "12165190", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT'S INJURY AND SUBSEQUENT DEMISE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AN ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY EXPIRED. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INJURY AND SUBSEQUENT DEMISE 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": "19763726", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO ALLEGEDLY SUSTAINED AN INJURY DURING A DA VINCI SURGICAL PROCEDURE ON (B)(6), 2008 AT AN UNSPECIFIED HOSPITAL AND SUBSEQUENTLY EXPIRED ON AN (B)(6) 2008. NO OTHER INFORMATION REGARDING THE REPORTED ALLEGATION WAS PROVIDED." }, { "mdr_text_key": "4413643", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO ALLEGEDLY SUSTAINED AN INJURY DURING A DA VINCI SURGICAL PROCEDURE AT AN UNSPECIFIED HOSPITAL AND SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE. NO OTHER INFORMATION REGARDING THE REPORTED ALLEGATION WAS PROVIDED." }, { "mdr_text_key": "19981165", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)" } ], "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": "12/30/2014;06/25/2015" } ] }