{ "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": "2955842-2023-10820", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20230222", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20221013", "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", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230223", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200123", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "126655", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230222", "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": "380601-40", "catalog_number": "", "lot_number": "380601", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/22/2023;03/31/2023;02/16/2024", "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": "20230222", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "61 YR", "patient_sex": "Male", "patient_weight": "87 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Failure to Anastomose", "Bowel Perforation", "Insufficient Information", "Failure to Anastomose", "Bowel Perforation", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20230125", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16424810", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230125", "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": "334642017", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "334642018", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT DA-VINCI ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) ON (B)(6) 2021 AS PART OF THE SP COLORECTAL IDE STUDY. THE PATIENT HAD AN ULTRALOW RESECTION WITH ANASTOMOSIS AND DIVERSION. THE PATIENT WAS OBSERVED WITH BOWEL PERFORATION THAT WAS DESCRIBED AS AN OPENING AT THE POSTERIOR LEVEL DURING A ROUTINE PROCTOSCOPY ON (B)(6) 2021. THE PATIENT WAS SEEN WEEKLY FOR STAGED TRANSRECTAL ASPIRATIONS STARTING (B)(6) 2022. THERE WAS NO ALLEGATION OF MALFUNCTION OF ANY DA-VINCI SYSTEM, INSTRUMENT, OR ACCESSORY DURING THE PROCEDURE. THE SURGEON BELIEVED THE REPORTED EVENT WAS RELATED TO THE PROCEDURE BUT NOT RELATED TO DA-VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT WAS REPORTED TO HAVE RECOVERED FULLY." }, { "mdr_text_key": "340136707", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT WAS SUSPECTED WITH ANASTOMOTIC DEHISCENCE THAT WAS DESCRIBED AS AN OPENING AT THE POSTERIOR LEVEL DURING A ROUTINE PROCTOSCOPY ON (B)(6)2021. ON (B)(6) 2021, THE PATIENT WAS ADMITTED FOR ACUTE RENAL FAILURE AND WAS CLINICALLY DEHYDRATED DURING HOSPITALIZATION. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2021 AFTER HIS RENAL FUNCTION RETURNED TO NORMAL. STARTING ON (B)(6) 2022, THE PATIENT WAS SEEN WEEKLY FOR STAGED TRANSANAL EXCISION AND DEBRIDEMENT, MECHANICAL AND WITH ELECTROCAUTERY OF THE PRESACRAL ULCER ACTIVITY. ON (B)(6) 2022, THE PATIENT REPORTED THAT THE DEHISCENCE WAS HEALING AND THE OSTOMY WAS FUNCTIONING PROPERLY." }, { "mdr_text_key": "340136708", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335305475", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335305476", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 31-MARCH-2023, THE FOLLOWING CORRECTED INFORMATION WAS RECEIVED FROM THE SITE: THE PATIENT WAS OBSERVED WITH ANASTOMOTIC DEHISCENCE (INITIALLY WAS REPORTED AS BOWEL PERFORATION) THAT WAS DESCRIBED AS AN OPENING AT THE POSTERIOR LEVEL DURING ROUTINE PROCTOSCOPY ON (B)(6) 2021 (IT WAS PREVIOUSLY REPORTED AS (B)(6) 2021). THE PATIENT WAS SEEN WEEKLY FOR STAGED TRANSRECTAL ASPIRATIONS AND DEBRIDEMENT STARTING (B)(6) 2021 (IT WAS PREVIOUSLY PREVIOUSLY REPORTED AS (B)(6) 2022)." }, { "mdr_text_key": "310044672", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE TRANSANAL RESECTION AND DEBRIDEMENT TO ADDRESS THE PRESACRAL ULCER CANNOT BE DETERMINED. THERE WAS NO REPORT OF ANY ISSUES WITH THE DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES. THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "310044673", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT DAVINCI ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) ON (B)(6) 2021 AS PART OF THE SP COLORECTAL IDE STUDY. APPROXIMATELY 1 YEAR AFTER THE SURGERY, IT WAS REPORTED THAT THE PATIENT WAS BEING SEEN ON A WEEKLY BASIS FOR STAGED TRANSRECTAL ASPIRATION / TRANSANAL EXCISION AND DEBRIDEMENT OF A PRESACRAL ULCER AND CAVITY. ACCORDING TO THE SURGEON, THE CAUSE OF THE PRESACRAL ULCER WAS DUE TO THE DEHISCENCE OF THE ANASTOMOSIS. INFORMATION REGARDING HOW LONG THE PATIENT HAS BEEN SEEN AT THE OUTPATIENT CLINIC FOR THE PROCEDURES WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IT WAS REPORTED THAT THE PATIENT HAS FULLY RECOVERED. A CLINICAL RESEARCH COORDINATOR REPORTED THAT THE CONDITION WAS RESOLVED WHEN THEY REVERSED THE ILEOSTOMY, THE DATE OF WHICH WAS NOT CURRENTLY AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. THE SURGEON ASSESSED THE EVENT AS NOT RELATED TO THE DA-VINCI ASSISTED PROCEDURE OR TO ANY OF THE DV SYSTEMS, INSTRUMENTS OR ACCESSORIES." } ], "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": "03/21/2023;04/21/2023;03/13/2024" } ] }