{ "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": "2955842-2023-14512", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230523", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20230427", "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": "20230523", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "257971", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230523", "brand_name": "DA VINCI", "generic_name": "DA VINCI", "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": "N/A", "catalog_number": "N/A", "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": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20230523", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "58 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury", "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20230427", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16989283", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230427", "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": "315845825", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 27-APR-2023, INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF HERNIA ARTICLE TITLED, \"IMPACT OF COVID-19 ON CLINICAL OUTCOMES OF ROBOTIC INGUINAL HERNIA REPAIR¿ (KUDSI, O.Y., ET AL., 2023).\" WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE MENTIONED. PATIENTS WHO UNDERWENT ROBOTIC INGUINAL HERNIA REPAIR (RIHR) 2 YEARS BEFORE AND AFTER 10-MAR-2020 WERE INCLUDED IN THE RETROSPECTIVE STUDY. A TOTAL OF 321 PATIENTS UNDERWENT RIHR DURING THE STUDY PERIOD, WITH 183 (57%) PATIENTS IN THE PRE-COVID GROUP AND 138 (43%) IN THE POST-COVID GROUP. ONE PATIENT WITH A HISTORY OF PREVIOUS OPEN IHR IN THE PRE-COVID GROUP SUFFERED FROM INTRAOPERATIVE BLEEDING SECONDARY TO INFERIOR EPI-GASTRIC VESSEL INJURY DURING PRE-PERITONEAL DISSECTION DUE TO EXTENSIVE ADHESIONS. THE BLEEDING WAS CONTROLLED WITH CLIPS. IN THE POST-COVID GROUP, ONLY ONE PATIENT EXPERIENCED AN INTRAOPERATIVE COMPLICATION DUE TO A PRIOR HISTORY OF BLADDER SURGERY AND POSTERIOR REPAIR. CONSEQUENTLY, THE BLADDER WAS INJURED DURING DISSECTION OF AN ANATOMICALLY DISTORTED PRE-PERITONEAL PLANE AND WAS EVENTUALLY REPAIRED WITH SUPERFICIAL SUTURES. EIGHT PATIENTS (4.4%) REQUIRED AN EMERGENCY ROOM VISIT WITHIN 30 DAYS OF DISCHARGE IN THE PRE-COVID GROUP VS. FIVE (3.6%) PATIENTS IN THE POST-COVID GROUP. ONE (0.7%) PATIENT IN THE POST-COVID GROUP REQUIRED HOSPITAL READMISSION DUE TO A HEMATOMA. 19 PATIENTS IN THE PRE-COVID GROUP EXPERIENCED ONE OR MORE POST OPERATIVE COMPLICATIONS VS 11 PATIENTS IN THE POST-COVID GROUP. OF THE 30 PATIENTS THAT HAD POST-OPERATIVE COMPLICATIONS, 25 OF THEM WERE CLAVIEN-DINDO GRADE 1, TWO OF THEM WERE GRADE II, TWO OF THEM WERE GRADE IIIB, ONE OF THEM WAS GRADE IV. INTUITIVE SURGICAL, INC, (ISI) MADE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED." }, { "mdr_text_key": "315845846", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THERE WAS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE. 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 REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF HERNIA ARTICLE, AND IT WAS MENTIONED OF THE 321 PATIENTS UNDERWENT RIHR DURING THE STUDY PERIOD, 30 PATIENTS HAD EXPERIENCED POST-OPERATIVE COMPLICATIONS WHICH INCLUDES CLAVIEN-DINDO GRADE 1 TO GRADE IV. ONE PATIENT WITH A HISTORY OF PREVIOUS OPEN IHR IN THE PRE-COVID GROUP SUFFERED FROM INTRAOPERATIVE BLEEDING SECONDARY TO INFERIOR EPI-GASTRIC VESSEL INJURY DURING PRE-PERITONEAL DISSECTION DUE TO EXTENSIVE ADHESIONS AND WAS CONTROLLED WITH CLIPS. ONE PATIENT EXPERIENCED AN INTRAOPERATIVE COMPLICATION AND HIS BLADDER WAS INJURED DURING DISSECTION OF AN ANATOMICALLY DISTORTED PRE-PERITONEAL PLANE AND WAS REPAIRED WITH SUPERFICIAL SUTURES." } ], "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": "" } ] }