{ "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": "2955842-2022-10174", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20220203", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "date_of_event": "20211014", "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", "Literature", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "SN", "manufacturer_contact_area_code": "408", "date_added": "20220203", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1373365", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220203", "brand_name": "DA VINCI SI", "generic_name": "PATIENT SIDE CART, 4-ARM", "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": "380614", "catalog_number": "N/A", "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": "", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/03/2022;02/10/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250820", "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": "20220203", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20220110", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13443413", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220110", "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": "289460762", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF A BRITISH JOURNAL OF SURGERY (BJS) OPEN ARTICLE TITLED, ¿OUTCOMES OF ROBOTIC LOW ANTERIOR RESECTION VERSUS TRANSANAL TOTAL MESORECTAL EXCISION FOR RECTAL CANCER¿ (BUAN, J. L. B., SO, W. Z., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING ROBOTIC LOW ANTERIOR RESECTION (RLAR) PROCEDURES WERE NOTED. PER THE ARTICLE, THE FOLLOWING WAS NOTED: \"RLAR WAS PERFORMED WITH THE DA VINCI SI VR (INTUITIVE SURGICAL, SUNNYVALE, CALIFORNIA, USA) SYSTEM IN TWO PHASES, WITH REDOCKING AS STANDARD PRACTICE AT THIS INSTITUTION,\" AND, \"IN THE RLAR GROUP SIX PATIENTS HAD COMPLICATIONS OF GRADE III AND ABOVE, OF WHOM FOUR HAD ANASTOMOTIC LEAKS, ONE HAD A POSTOPERATIVE BILOMA FROM A SYNCHRONOUS LIVER RESECTION, AND ONE HAD NARROWING OF THE AFFERENT LIMB OF THE DE-FUNCTIONING ILEOSTOMY THAT REQUIRED SURGICAL REVISION.\" ISI FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION: THE AUTHOR WAS UNABLE TO PROVIDE THE NAMES OF THE SURGEONS BUT CONFIRMED THAT THE STUDY HAD (B)(6) SURGEONS INVOLVED IN THESE CASES. WITH REGARDS TO THE PATIENT WITH THE BILOMA, THE PATIENT REQUIRED A LIVER RESECTION DUE TO LIVER METASTASIS. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE THAT CAUSED/CONTRIBUTED TO THE COMPLICATION. THE SURGEON STATED THAT BILOMA IS A KNOWN COMPLICATION AFTER LIVER RESECTION. THE BILOMA WAS TREATED WITH ANTIBIOTICS. WITH REGARDS TO THE PATIENT WHO HAD NARROWING OF THE AFFERENT LIMB OF THE ILEOSTOMY, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE THAT CAUSED/CONTRIBUTED TO THE COMPLICATION. THE SURGEON BELIEVES THE CAUSE OF THE COMPLICATION WAS DUE TO TECHNICAL REASONS AS THE BOWEL LOOP WAS EDEMATOUS. DEMOGRAPHIC PATIENT INFORMATION WAS ENQUIRED BUT NOT PROVIDED BY THE AUTHOR." }, { "mdr_text_key": "289460763", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE BILOMA IS UNKNOWN. ACCORDING TO THE SURGEON, BILOMA IS A KNOWN COMPLICATION OF LIVER RESECTION AND THE NARROWING OF THE AFFERENT LIMB OF THE ILEOSTOMY WAS ATTRIBUTED TO TECHNICAL ISSUES. THE SURGEON CONFIRMED THERE IS NO ALLEGATION OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENTS. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS IS NOT POSSIBLE DUE TO LACK OF SYSTEM AND INSTRUMENT DETAIL, EVENT/PROCEDURE DATE, AND CONFIRMATION OF SITE LOCATION. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE ARTICLE TITLED, \"OUTCOMES OF ROBOTIC LOW ANTERIOR RESECTION (RLAR) VERSUS TRANSANAL TOTAL MESORECTAL EXCISION (TATME) FOR RECTAL CANCER,¿ POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI-ASSISTED SURGICAL PROCEDURES WERE NOTED. WITHIN THE JOURNAL ARTICLE, ONE PATIENT WITH A POST-OPERATIVE BILOMA WAS TREATED WITH ANTIBIOTICS AND ANOTHER PATIENT WITH A NARROWING OF THE AFFERENT LIMB OF THE DE-FUNCTIONING ILEOSTOMY REQUIRED SURGICAL REVISION. REFER TO THE MDR WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL INFORMATION REGARDING AN ANASTOMOTIC LEAKAGE THAT WAS CITED IN THE ARTICLE." }, { "mdr_text_key": "328600567", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "328600568", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPON FURTHER REVIEW OF THE JOURNAL ARTICLE, IT WAS NOTED THAT (B)(4) PATIENTS IN THE RLAR GROUP EXPERIENCED CLAVIEN-DINDO GRADE 0-II COMPLICATIONS. ALTHOUGH THE NUMBER OF PATIENTS ASSOCIATED WITH EACH GRADE COMPLICATION IS UNKNOWN AND DETAILS REGARDING THE COMPLICATIONS ARE UNKNOWN, THIS SUPPLEMENTAL CORRECTION MDR IS BEING SUBMITTED TO REPORT THE CLAVIEN-DINDO GRADE I-II COMPLICATIONS." }, { "mdr_text_key": "327374693", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "327374694", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN SECTION: G6, H2. CORRECTED INFORMATION CAN BE FOUND IN SECTION H10/H11 - THE INCORRECT PATIENT IDENTIFIER WAS NOTED IN THE INITIAL SUBMISSION. CORRECTED INFORMATION: REFER TO THE MDR WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL INFORMATION REGARDING ANASTOMOTIC LEAKAGES THAT ARE CITED IN THE ARTICLE." } ], "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": "02/03/2022;03/10/2022" } ] }