{ "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": "I", "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": "2955842-2018-00008", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20180104", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20160711", "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": [ "CONSUMER", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20180104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "7803", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180104", "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 A60P9B", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/12/2018", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20180104", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Unspecified Infection", "Bowel Perforation", "Death", "Unspecified Infection", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20171212", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7166141", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20171212", "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": "96445900", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS ATTEMPTED TO CONTACT THE SITE'S RISK MANAGEMENT DEPARTMENT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSES OF THE PATIENT'S ALLEGED OPERATIVE COMPLICATIONS AND SUBSEQUENT DEATH ARE UNKNOWN. ALSO, THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED RIGHT UPPER PULMONARY LOBECTOMY PROCEDURE, A BOWEL PERFORATION WAS IDENTIFIED A FEW WEEKS LATER AND THE PATIENT SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S OPERATIVE COMPLICATIONS AND SUBSEQUENT DEATH ARE UNKNOWN." }, { "mdr_text_key": "96445901", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON DECEMBER 12, 2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5073827, WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6), MY MOTHER (B)(6), (DOB (B)(6)) WAS OPERATED ON VIA DA VINCI ROBOTIC PROCEDURE BY TWO PHYSICIAN AT ROPER HOSPITAL IN (B)(6) FOR RIGHT UPPER LOBECTOMY. SHE IMMEDIATELY COMPLAINED OF ABDOMINAL PAIN (NEAR 8TH INTERCOSTAL SPACE WHERE CAMERA FROM ROBOT WAS INSERTED). THAT AFTERNOON FOLLOWING PROCEDURE, AND EVERY DAY THEREAFTER (DOCUMENT IN NURSE'S NOTES) UNTIL IT WAS DISCOVERED A FEW WEEK [SIC] LATER, HER RIGHT COLON HAD BEEN PERFORATED FOR SOME TIME AND EMERGENCY SURGERY WAS PERFORMED, AND THEN ALMOST BLED OUT FROM ANASTOMOSIS. THE DELAYED DIAGNOSIS OF PERFORATED COLON RESULTED IN A HEALTH DECLINE THAT RESULTED IN HER DEATH ON (B)(6) 2016. SHE TESTED POSITIVE FOR C. FREUNDII, CITROBACTER FREUNDII IS A SPECIES FACULTATIVE ANEROBIC GRAM-NEGATIVE BACTERIA OF THE (ENTERFOBACTERIACEAE FAMILY) IN HER RIGHT LUNG, AND WHITE BLOOD CELL COUNT WAS 59,000 FROM BACTERIA'S AND STOOL LEAKING OUT INTO ABDOMINAL CAVITY. SHE ALSO TESTED POSITIVE FOR SEVERAL OTHER BACTERIA'S INCLUDING CANDIDA TROPICALIS (FUNGUS). THANK YOU FOR LOOKING INTO THIS MATTER TO HELP WITH COMPLIANCE AND MAY BE PREVENTING THIS FROM HAPPENING TO OTHER PTS AND FAMILIES." }, { "mdr_text_key": "106045979", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 01/12/2018, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SITE REGARDING THE REPORTED EVENT: THE RISK MANAGER CONFIRMED THAT THE PATIENT UNDERWENT A DA VINCI-ASSISTED SURGICAL PROCEDURE AT THE SITE ON (B)(6) 2016 WHICH WAS NOT RECORDED ON VIDEO. NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE WHICH WAS COMPLETED SUCCESSFULLY. THE PATIENT DEVELOPED THE FOLLOWING: POST-OPERATIVE PNEUMONIA, PLEURAL SPACE INFECTION, POST-OPERATIVE ILEUS, ADHESIONS, SUSPECTED VOLVULUS. THE RISK MANAGER EXPLAINED THAT THE COMPLICATIONS ARE A COMMON RISK OF SURGERY POST ANESTHESIA. AN NG TUBE WAS PLACED AND THE ILEUS WAS RESOLVING. ON (B)(6) 2016, THE PATIENT UNDERWENT AN EXPLORATORY LAP PROCEDURE AND A PERFORATION IN THE CECUM OF THE BOWEL WAS FOUND. THE RISK MANAGER INDICATED THAT THE CAUSE OF THE BOWEL PERFORATION WAS FROM SUSPECTED VOLVULUS AND ADHESIONS. AS A RESULT OF THE BOWEL DEFECT, A SMALL SECTION OF THE BOWEL WAS RESECTED. THE PATIENT REPORTEDLY EXPIRED ON (B)(6) 2016. AN AUTOPSY WAS PERFORMED AND THE CAUSE OF DEATH WAS NOTED AS RESPIRATORY FAILURE. THE RISK MANAGER INDICATED THAT THE SITE DOES NOT BELIEVE THE DA VINCI SURGICAL SYSTEM CAUSED/CONTRIBUTED TO THE PATIENT'S DEATH. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT IS NO LONGER DEEMED REPORTABLE AS AN ADVERSE EVENT DUE TO THE FOLLOWING CONCLUSION: THE SITE'S RISK MANAGER INDICATED THAT THE PATIENT'S POST-OPERATIVE COMPLICATION (I.E. BOWEL PERFORATION) WAS CAUSED BY SUSPECTED VOLVULUS AND ADHESIONS. IN ADDITION, THE RISK MANAGER INDICATED THAT THE SITE DOES NOT BELIEVE THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED." } ], "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": "01/25/2018" } ] }