{ "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": "2955842-2022-13918", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220909", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "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", "Literature", "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": "20220909", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1139982", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220909", "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", "catalog_number": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": "NJ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20220909", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Impaired Healing", "Bowel Perforation", "Impaired Healing", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20220812", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15396950", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220812", "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": "299664098", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN UROLOGY JOURNAL ARTICLE TITLED, ¿SINGLE PORT VS MULTIPORT ROBOTIC PYELOPLASTY: PROPENSITY-SCORE MATCHED ANALYSIS OF PERIOPERATIVE AND FOLLOW-UP OUTCOMES¿ (HARRISON, R., AHMED, M., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING SINGLE-PORT (SP) ROBOTIC-ASSISTED PYELOPLASTY (RAP) PROCEDURES WERE NOTED. IN THE ARTICLE, THE FOLLOWING IS NOTED: ¿AN INTRAOPERATIVE COMPLICATION OCCURRED DURING ONE SP-RAP CASE. WHILE INCISING THE PERITONEUM TO ACCESS THE ABDOMINAL CAVITY, A SMALL ENTEROTOMY WAS NOTED IN A PORTION OF THE SMALL BOWEL THAT WAS ADHERENT TO THE PERITONEUM IN A PATIENT WITH PRIOR ABDOMINAL SURGERY. THE INJURED AREA WAS REPAIRED IN TWO LAYERS, USING 3-0 VICRYL FOR THE MUCOSA, AND 3-0 SILK FOR THE SEROSA IN A LEMBERT FASHION.¿ ADDITIONALLY, IT IS DOCUMENTED: ¿ONE SP-RAP PATIENT UNDERWENT SURGICAL DEBRIDEMENT FOR A POORLY HEALING, LEFT LOWER ABDOMINAL QUADRANT WOUND (CLAVIEN CLASS IIIB).\" INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "299664099", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATIONS CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM/INSTRUMENT LOGS CANNOT BE CONDUCTED DUE TO LACK OF SYSTEM AND INSTRUMENT DETAIL, AND EVENT/PROCEDURE DATES. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: WITHIN THE UROLOGY ARTICLE TITLED, ¿SINGLE PORT VS MULTIPORT ROBOTIC PYELOPLASTY: PROPENSITY-SCORE MATCHED ANALYSIS OF PERIOPERATIVE AND FOLLOW-UP OUTCOMES,¿ TWO OPERATIVE COMPLICATIONS INVOLVING DA VINCI-ASSIST PYELOPLASTY PROCEDURES WERE NOTED. IN ONE CASE WHILE INCISING THE PERITONEUM TO ACCESS THE ABDOMINAL CAVITY, A SMALL ENTEROTOMY WAS NOTED IN A PORTION OF THE SMALL BOWEL THAT WAS ADHERENT TO THE PERITONEUM IN A PATIENT WITH PRIOR ABDOMINAL SURGERY. THE INJURED AREA WAS REPAIRED WITH SUTURES. IN ONE OTHER CASE, A PATIENT UNDERWENT SURGICAL DEBRIDEMENT FOR A POORLY HEALING, LEFT LOWER ABDOMINAL QUADRANT WOUND. THE CAUSES OF THE COMPLICATIONS ARE UNKNOWN." } ], "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": "" } ] }