{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2023-11964", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20230414", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20230414", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190613", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "392384", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230414", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "380601-34", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/11/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20230414", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "64 YR", "patient_sex": "Male", "patient_weight": "72 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Failure to Anastomose", "Failure to Anastomose" ] } ], "distributor_city": "", "date_report": "20230317", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16744182", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230317", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "339347198", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON (B)(6) 2023, THE PATIENT REPORTED NO FURTHER ANAL PAIN DURING AN OUTPATIENT VISIT AND THE ANTIBIOTICS WERE STOPPED AT THIS TIME. THE ANASTOMOTIC LEAKAGE WAS CONSIDERED RESOLVED." }, { "mdr_text_key": "339347199", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "313336613", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE ANASTOMOTIC LEAKAGE CANNOT BE DETERMINED. THERE WAS NO REPORT OF A DA VINCI PRODUCT MALFUNCTION AND THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A SYSTEM LOG SHOWED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED LAR PROCEDURE, THE PATIENT WAS FOUND WITH DEHISCENCE ON THE RIGHT POSTERIOR OF THE ANASTOMOSIS SITE. AS THE PATIENT REFUSED AN ILEOSTOMY SURGERY, THE PATIENT WAS PRESCRIBED WITH CEFPODOXIME PROXETIL 200 TWICE A DAY (BID) AND METRONIDAZOLE 500 THREE TIMES A DAY (TID)." }, { "mdr_text_key": "313336614", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION (LAR) PROCEDURE ON (B)(6) 2023 AS PART OF THE SP COLORECTAL IDE STUDY. THE PATIENT WAS FOUND WITH DEHISCENCE ON THE RIGHT POSTERIOR OF THE ANASTOMOSIS SITE ON ABDOMINAL AND PELVIC CT (AP-CT) IMAGE ON (B)(6) 2023 DURING A ROUTINE EXAMINATION PRIOR TO CHEMOTHERAPY. THE PATIENT HAD SLIGHT ANAL PAIN, BUT THE C-REACTIVE PROTEIN (CRP: 0.41 MG/DL) AND WBC(6.36 K/UL) RESULT WERE NOT HIGH. THE PATIENT WAS RECOMMENDED FOR ILEOSTOMY SURGERY, BUT THE PATIENT REFUSED THE TREATMENT. THEREFORE, THE PATIENT WAS PRESCRIBED WITH CEFPODOXIME PROXETIL 200 TWICE A DAY (BID) AND METRONIDAZOLE 500 THREE TIMES A DAY (TID). THE INVESTIGATOR ASSESSED THE REPORTED EVENT AS TO NOT RELATED TO THE DA-VINCI DEVICE BUT POSSIBLY RELATED TO THE DA VINCI-ASSISTED PROCEDURE, AND PROBABLY RELATED TO THE PATIENT UNDERLYING DISEASE. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES DURING THE PROCEDURE. THERE WERE NO INTRA-OPERATIVE OR ANY OTHER POST-OPERATIVE COMPLICATIONS THAT ARE RELATED TO THE REPORTED EVENT. THE PATIENT HAD RECEIVED NEOADJUVANT THERAPY PRIOR TO THE DA VINCI-ASSISTED SURGERY, WHICH INCLUDES RADIATION AND CHEMOTHERAPY. THE INVESTIGATOR THOUGHT THAT THE PATIENT'S TISSUE MAY HAVE BEEN WEAKENED BY THE NEOADJUVANT THERAPY, AND POSSIBLY RELATED TO THE REPORTED EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/03/2024" } ] }