{ "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": "2955842-2013-03953", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131003", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130502", "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": "20131004", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "500412", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131003", "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": [ "Leak/Splash" ], "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": "20131003", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "170", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20130905", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3385091", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140524", "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": "3750197", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC., (ISI) RECEIVED INFORMATION OF A PATIENT WHO UNDERWENT A DA VINCI SI BARIATRIC BAND SURGICAL PROCEDURE ON (B)(6) 2013. THE PATIENT WAS ADVISED AFTER THE DA VINCI SURGERY THAT THERE WAS A LEAK THAT NEEDED TO BE FIXED. APPROXIMATELY ON (B)(6) 2013, ANOTHER SURGERY WAS PERFORMED TO DRAIN THE PATIENT'S BODY CAVITY (10 LITERS WERE REMOVED). ON AN UNSPECIFIED DATE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED." }, { "mdr_text_key": "12063289", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED SUPPLEMENTAL INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED ROBOTIC PROCEDURE-SLEEVE GASTRECTOMY FOR MORBID OBESITY ASSOCIATED WITH MULTIPLE-CO-MORBIDITIES ON (B)(6) 2013. THE PROVIDED LEGAL DOCUMENT CLAIMS THAT THE PATIENT DIED ON (B)(6) 2013 DUE TO MULTI-ORGAN SYSTEM FAILURE, AND SEPTIC SHOCK. SUPPLEMENTAL INFORMATION WAS REVIEWED ON (B)(6) 2014. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND OTHER MEDICAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING THE OPERATION. PERTINENT FINDINGS INCLUDE CIRRHOTIC AND NODULAR LIVER. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO THE ICU POSTOPERATIVELY. POSTOPERATIVE IMAGING STUDIES (GASTROGRAFIN) SHOWED NO LEAKAGE OR OBSTRUCTION. ON (B)(6) 2013, THE PATIENT WAS EXPERIENCING INTERMITTENT FEVER WITH LEUKOCYTOSIS PER INFECTIOUS DISEASE CONSULTATION. PER THE MEDICAL NOTE, A WORKUP REVEALED INTRA-ABDOMINAL FLUID AND BLOOD CULTURES OBTAINED FROM THE CENTRAL CATHETER GREW (B)(6) IN ONE OF TWO BOTTLES. THE CATHETER WAS SUBSEQUENTLY REMOVED. ON (B)(6) 2013, THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY, EXPLORATORY LAPAROTOMY, AND EVACUATION OF ASCITES FOR SEPSIS AND ABDOMINAL ASCITES. PER THE OPERATIVE REPORT, AN EXTENSIVE WORKUP WAS DONE INCLUDING TWO UPPER GIS AND A CT SCAN WITH CONTRAST WHERE NO SITE OF LEAKAGE WAS IDENTIFIED. THE PROCEDURE WAS INITIALLY A DIAGNOSTIC LAPAROSCOPY. HOWEVER, IT WAS CONVERTED TO A LAPAROTOMY SECONDARY TO ATTEMPTING TO ACCESS THE ABDOMINAL CAVITY. NO PUS OR PURULENT FLUID WAS NOTED. NO FECULENT MATERIAL WAS NOTED. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2013, THE PATIENT DIED. NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE ADDITIONAL INFORMATION, THIS COMPLAINT IS STILL BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT REPORTEDLY DIED DUE TO MULTI-ORGAN SYSTEM FAILURE AND SEPTIC SHOCK 10 DAYS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE." }, { "mdr_text_key": "11194555", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. 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: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL BARIATRIC BAND SURGICAL PROCEDURE." } ], "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": "06/05/2014" } ] }