{ "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": "Injury", "report_number": "2955842-2015-01440", "type_of_report": [ "" ], "product_problem_flag": "N", "date_received": "20151125", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20151023", "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": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20151125", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "781947", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20151125", "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 A6.0P9", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20151125", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Low Blood Pressure/ Hypotension" ] } ], "distributor_city": "", "date_report": "20151029", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5250995", "removal_correction_number": "", "number_devices_in_event": "", "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": "32187682", "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 POST-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION FROM THE SURGEON THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE DEVELOPED A SPLENIC HEMATOMA AND REQUIRED ADDITIONAL MEDICAL INTERVENTION. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "32187683", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LEFT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS ON POST-OPERATIVE DAY 1. THE PATIENT WAS FOUND TO HAVE A HEMATOMA ON HER SPLEEN AND REMAINED IN THE ICU FOR 2 DAYS. THE PATIENT'S HEMOGLOBIN REPORTEDLY DROPPED 5 GRAMS AND SHE WAS GIVEN 2 UNITS OF BLOOD. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS AND THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED. THE CSR INDICATED THAT THE SURGEON BELIEVED THAT THE WRISTS OF THE DA VINCI INSTRUMENTS OR TRADITIONAL LAPAROSCOPIC INSTRUMENTS USED THROUGH THE ASSISTANT PORT MADE CONTACT WITH THE SPLEEN WHICH CAUSED THE HEMATOMA. ON (B)(6) 2015, ISI CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON INDICATED THAT SHE INSERTED THE ASSISTANT TROCAR INTO THE 9TH INTERSPACE WHICH IS A FEW MILLIMETERS ABOVE THE DIAPHRAGM. THE SURGEON BELIEVES THE ASSISTANT SURGEON MAY HAVE BLUNTLY HIT THE SPLEEN THROUGH THE DIAPHRAGM (WITHOUT CREATING A HOLE IN THE DIAPHRAGM) WHILE INSERTING INSTRUMENTS. THERE WAS NO HOLE IN THE DIAPHRAGM. THE SURGEON SPOKE TO THE ASSISTANT SURGEON AND WAS INFORMED THAT HE DID NOT NOTICE HITTING ANYTHING DURING THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON POST-OPERATIVE DAY (POD) 2 AND 3, THE PATIENT EXPERIENCED HYPOTENSION. A CT-SCAN PERFORMED ON POD 3 REVEALED A 12 CM SPLENIC HEMATOMA. THE SURGEON AND A TRAUMA SURGEON REVIEWED THE CT-SCAN AND CLASSIFIED THE COMPLICATION AS A GRADE III SPLENIC INJURY. DUE TO THE HEMATOMA, THE PATIENT WAS TREATED WITH 2 UNITS OF PACKED RED BLOOD CELLS (PRBC) AND UNDERWENT EMBOLIZATION OF THE SPLENIC ARTERY. PER THE SURGEON, THE PATIENT WAS DISCHARGED ON (B)(6) 2015 AND IS CURRENTLY DOING WELL." } ], "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": "" } ] }