{ "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": "Injury", "report_number": "2955842-2018-10771", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20181220", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20181023", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20181220", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1026833", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181220", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "DA VINCI SI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20181220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Blood Loss", "Hematoma", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20181128", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8186958", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20181128", "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": "131139815", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE ALLEGED POST-OPERATIVE COMPLICATION SUSTAINED BY THE PATIENT. 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) 2018. 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 SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND A HEMATOMA WAS IDENTIFIED. AS A RESULT, THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE TO CLEAN THE AREA OF THE HEMATOMA AND TWO DRAINS WERE PLACED. HOWEVER, THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATIONS ARE UNKNOWN." }, { "mdr_text_key": "131139816", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT CAME BACK SEVERAL WEEKS LATER WITH A HEMATOMA AND BLEEDING. THE SURGEON PERFORMED AN OPEN SURGICAL PROCEDURE AND CLEANED THE AREA AROUND THE HEMATOMA. ACCORDING TO THE INITIAL REPORTER, THE SURGEON INDICATED THAT EVERYTHING LOOKED SEALED FROM WHAT HE COULD SEE AND THERE WAS NO EXTRA BLEEDING. IT WAS ASSUMED THAT THE STAPLES WERE INTACT. THE PATIENT WAS REPORTEDLY STABLE. ON (B)(4) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. THERE WAS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE ALSO NO REPORTED INTRA-OPERATIVE COMPLICATIONS. THE SURGEON WAS NOT SURE WHAT CAUSED THE POST-OPERATIVE HEMATOMA AND BLEEDING. ACCORDING TO THE CSR, THE HEMATOMA APPEARED TO BE NEAR THE STAPLE LINE. HOWEVER, THERE WERE NO ISSUES IDENTIFIED WITH THE STAPLE LINE INTRA-OPERATIVELY OR POST-OPERATIVELY. THE CSR CLARIFIED THAT THE SECOND SURGICAL PROCEDURE WAS PERFORMED LAPAROSCOPICALLY. THE SURGEON CLEANED UP THE HEMATOMA AND PLACED TWO DRAINS. PER THE SURGEON, THE PATIENT WAS DOING FINE." } ], "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": "" } ] }