{ "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": "2955842-2013-04335", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131011", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20120509", "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": "20131011", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "521746", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131011", "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": "IL", "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": "20131011", "sequence_number_treatment": [ "DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "72 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Unspecified Infection", "Perforation", "Respiratory Distress", "Scarring", "Excessive Tear Production", "Injury" ] } ], "distributor_city": "", "date_report": "20130912", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3406094", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140331", "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": "16876286", "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 THAT UNDERWENT A DA VINCI POLYP REMOVAL PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'SURGERY TOOK 5 1/2 HOURS INSTEAD OF 2 DUE TO SCAR TISSUE , HAD TO INTUBATE HIM BECAUSE HE COULD NOT BREATHE, A TEAR IN HIS INTESTINE, DEVELOPED A RASH WHOLE BACK TURNED BACK DOCTORS DID NOTHING, PASSED AWAY FOLLOWING MORNING AUTOPSY SHOWS AN INFECTION.'" }, { "mdr_text_key": "15762195", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) WAS PROVIDED WITH THE PATIENT'S DA VINCI SURGERY OPERATIVE (OP) REPORT (S) AND SUBSEQUENT MEDICAL RECORDS. ACCORDING TO THE PATIENT'S DA VINCI SURGERY OP REPORT, THE PATIENT UNDERWENT A DA VINCI RIGHT HEMI-COLECTOMY PROCEDURE FOR A RIGHT COLON POLYP. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. PERTINENT FINDINGS INCLUDE SEVERE INTRABDOMINAL ADHESIONS. THE SURGEON'S DICTATED OP REPORT STATES, PRIOR TO DOCKING THE ROBOT, APPROXIMATELY 1 HOUR WAS SPENT LYSING ADHESIONS WITH OMENTUM DENSELY ADHERENT INTO THE PELVIS. ACCORDING TO THE INFORMATION PROVIDED IN THE PATIENT'S SUBSEQUENT MEDICAL RECORDS, THE PATIENT PRESENTED WITH THE FOLLOWING: ON (B)(6) 2012, THE PATIENT'S VITAL SIGNS BEGAN TO WORSEN AND A CT SCAN SHOWED SIGNS OF LEAKING ABDOMINAL CONTRAST. ON (B)(6) 2012, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY AND IT WAS DISCOVERED THAT THE PATIENT HAD A SMALL BOWEL INJURY. THE DAMAGE TO THE PATIENT'S BOWEL WAS RESECTED. POST-OPERATIVELY THE PATIENT'S THE COLONIC ANASTOMOSIS WAS FOUND TO BE INTACT. AN ABDOMINAL WASHOUT WAS ALSO PERFORMED. ON (B)(6) 2012, THE PATIENT DEVELOPED RESPIRATORY DISTRESS AND WAS PLACED ON A VENTILATOR. THE PATIENT EXHIBITED SIGNS OF ILEUS. ON (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH SEPSIS WITH UNCLEAR ETIOLOGY (COLON, SMALL BOWEL, OR LUNG). FROM (B)(6) 2012, THE PATIENT'S CONDITION WORSENED. IT WAS SUSPECTED THAT THE PATIENT HAD NECROTIZING FASCIITIS. THE PATIENT EXPIRED ON (B)(6) 2012. ON (B)(4) 2014, ISI RECEIVED ADDITIONAL INFORMATION FROM THE HOSPITAL REGARDING THE REPORTED EVENT. ACCORDING TO THE HOSPITAL'S RISK MANAGER, THE HOSPITAL'S INVESTIGATION DETERMINED THAT THE INJURY TO THE PATIENT'S BOWEL OCCURRED DUE TO THE PATIENT'S EXTENSIVE ADHESIONS AND THE COMPLEXITY TO REMOVING THE ADHESIONS. THE DA VINCI SURGICAL PROCEDURE WAS ALSO LENGTHY. THE RISK MANAGER INDICATED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THE RISK MANAGER INDICATED THAT THE PATIENT'S DEMISE WAS DUE TO NECROTIZING FASCIITIS AND THE PATIENT'S CONTRACTION OF THE DISEASE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. NO OTHER INFORMATION WAS PROVIDED. BASED ON THE ADDITIONAL INFORMATION PROVIDED, ISI HAS DETERMINED THAT THE REPORTED INCIDENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT, AS THE INFORMATION PROVIDED DID NOT SUGGEST THAT THE BOWEL INJURY SUSTAINED BY THE PATIENT AND THE PATIENT'S SUBSEQUENT DEMISE WERE CAUSED BY THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, BUT RATHER OCCURRED DUE TO THE PATIENT'S EXTENSIVE ADHESIONS AND SUBSEQUENT CONTRACTION OF NECROTIZING FASCIITIS. THERE WAS NO REPORT BY THE HOSPITAL THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED. THIS MEDWATCH REPORT IS BEING RETRACTED AS A REPORTABLE EVENT BASED ON THE ADDITIONAL INFORMATION PROVIDED." }, { "mdr_text_key": "17048190", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT'S DEATH. 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 REPORTEDLY EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND EXPIRED ON THE FOLLOWING MORNING." } ], "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": "06/25/2014" } ] }