{ "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": "2955842-2022-10179", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220203", "manufacturer_address_2": "", "pma_pmn_number": "", "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": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1372532", "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": "02/02/2022", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250806", "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": [ "Failure to Anastomose", "Abscess", "Failure to Anastomose", "Abscess" ] } ], "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": "13446780", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "289499897", "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.\" ONLY ONE OF THE PATIENTS WHO EXPERIENCED AN ANASTOMOTIC LEAK REQUIRED A RE-OPERATION IN WHICH THE PELVIC ABSCESS WAS DRAINED TRANSANALLY AND THE LEAK WAS MANAGED WITH THE ENDO-SPONGEVR SYSTEM. ADDITIONALLY, PER THE JOURNAL ARTICLE, THE FOLLOWING IS NOTED: \"DISTAL TRANSECTION WAS PERFORMED WITH ENDOSCOPIC STAPLERS.\" HOWEVER, IT IS ALSO NOTED WITHIN THE ARTICLE, \"ANASTOMOSES WERE PERFORMED EITHER WITH A CIRCULAR STAPLER OR, IN THE EVENT OF VERY DISTAL TRANSECTION FOR LOW TUMOURS, A HANDSEWN COLOANAL ANASTOMOSIS.\" INTUITIVE SURGICAL, INC. (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 KOREAN AND SINGAPORE SURGEONS INVOLVED IN THESE CASES. THERE WERE NO DA VINCI PRODUCT ISSUES REPORTED IN THE DATABASE REGARDING THE ANASTOMOSIS LEAKAGE INCIDENTS. THERE WERE NO ALLEGATIONS THAT A MALFUNCTION OF A DA VINCI SYSTEM/INSTRUMENT/ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE THAT CAUSED/CONTRIBUTED TO THE COMPLICATIONS. WITH REGARDS TO THE OTHER 3 PATIENTS WHO EXPERIENCED ANASTOMOTIC LEAKS, THE AUTHOR INDICATED, \"THE CONSERVATIVE MANAGEMENT IS TYPICALLY ANTIBIOTICS AND DRAINAGE PERCUTANEOUSLY DONE.\" DEMOGRAPHIC INFORMATION WAS ENQUIRED BUT NOT PROVIDED BY THE AUTHOR." }, { "mdr_text_key": "289499898", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE ANASTOMOTIC LEAKAGES ARE UNKNOWN. THE AUTHOR 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 WAS NOT POSSIBLE DUE TO LACK OF SYSTEM AND INSTRUMENT DETAILS, EVENT/PROCEDURE DATES, AND CONFIRMATION OF SITE LOCATION(S). NO ADDITIONAL TECHNICAL REVIEW WAS REQUIRED BASED ON THE COMPLAINT SINCE THE EVENT DATE, SITE NAME, AND DA VINCI SYSTEM INFORMATION ARE UNKNOWN. 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 VERSUS TRANSANAL TOTAL MESORECTAL EXCISION FOR RECTAL CANCER,¿ POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI-ASSISTED SURGICAL PROCEDURES WERE NOTED. THERE WERE 4 ANASTOMOTIC LEAKAGES, OUT OF WHICH 1 PATIENT REQUIRED A RE-OPERATION TO ADDRESS THE LEAK. THE REMAINING 3 PATIENTS UNDERWENT CONSERVATIVE MANAGEMENT WITH ANTIBIOTICS AND PERCUTANEOUS DRAINAGE. AT THIS TIME, THE ROOT CAUSES OF THE ANASTOMOTIC LEAKAGES ARE UNKNOWN. REFER TO THE MDR WITH PATIENT IDENTIFIER # (B)(6)FOR ADDITIONAL INFORMATION REGARDING THE OTHER POST-OPERATIVE COMPLICATIONS (I.E. POST-OPERATIVE BILOMA TREATED WITH ANTIBIOTICS AND NARROWING OF THE AFFERENT LIMB OF THE DE-FUNCTIONING ILEOSTOMY REQUIRING SURGICAL REVISION) THAT ARE CITED IN THE ARTICLE. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE." }, { "mdr_text_key": "327374268", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "327374269", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: SECTION D, G3, G6, H2 AND H10. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT FROM THE AUTHOR: IN REFERENCE TO THE STATEMENT IN THE ARTICLE, \"DISTAL TRANSECTION WAS PERFORMED WITH ENDOSCOPIC STAPLERS,\" THE AUTHOR CONFIRMED THAT THE STAPLERS USED WERE LAPAROSCOPIC STAPLERS AND NOT DA VINCI STAPLERS." } ], "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": "03/02/2022" } ] }