{ "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": "2955842-2024-18113", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240814", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240115", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "", "manufacturer_contact_area_code": "408", "date_added": "20240815", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1176575", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240814", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "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": "N", "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": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "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": "20240814", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "61 YR", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "Vomiting", "Unspecified Respiratory Problem", "Unspecified Infection", "Vomiting", "Unspecified Respiratory Problem" ] } ], "distributor_city": "", "date_report": "20240717", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19988517", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240717", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "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": "349335038", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE WAS PERFORMED WHICH IS BASED ON A RETROSPECTIVE STUDY INVOLVING 144 PATIENTS WITH TYPE I¿IV HIATAL HERNIAS WHO UNDERWENT ELECTIVE DA VINCI-ASSISTED HERNIA REPAIR FROM 2016 TO 2019. THE STUDY AIMED TO ASSESS THE OUTCOMES OF A NOVEL TECHNIQUE FOR APPROXIMATING THE HIATUS USING V-LOCTM SUTURES, FOCUSING ON LENGTH OF STAY, READMISSION, AND RECURRENCE RATES. THE STUDY CONCLUDED THAT ROBOTIC REPAIR METHOD IS SAFE AND EFFECTIVE, WITH RESULTS COMPARABLE TO NATIONALLY PUBLISHED DATA ON LAPAROSCOPIC HIATAL HERNIA REPAIRS. THE AVERAGE PATIENT AGE WAS 61, WITH A MAJORITY BEING FEMALE. THE MOST COMMON COMPLICATION WAS CAPNOTHORAX (11%), WHICH REQUIRED PIGTAIL CATHETER PLACEMENT. NINETY-FIVE PERCENT OF PATIENTS WERE DISCHARGED HOME, AND 7% WERE READMITTED WITHIN 30 DAYS FOR VARIOUS ISSUES, INCLUDING DYSPHAGIA, EMESIS, MEDIASTINAL COLLECTION, INCISIONAL HERNIA, MALFUNCTIONING J-TUBE (A 3RD-PARTY MANUFACTURER PRODUCT), SUBCUTANEOUS EMPHYSEMA, AND SURGICAL SITE INFECTION. SIX RECURRENCES REQUIRED REOPERATION, PRIMARILY DUE TO SYMPTOMATIC RE-HERNIATION OR HIATUS ENLARGEMENT. THE STUDY CONCLUDED THAT ELECTIVE ROBOTIC HIATAL HERNIA REPAIR WITH FUNDOPLICATION AND PRIMARY CLOSURE OF THE HIATUS WITH V-LOCTM AND NONABSORBABLE SUTURE WITHOUT MESH IS SAFE AND EFFECTIVE. THE ROBOTIC APPROACH HAS SIMILAR OPERATIVE TIMES, LENGTHS OF STAY, AND COMPLICATIONS COMPARED TO NATIONALLY PUBLISHED DATA ON LAPAROSCOPIC HIATAL HERNIA REPAIRS. THE STUDY HAD LIMITATIONS, INCLUDING A SHORT FOLLOW-UP PERIOD OF 10 MONTHS, INCONSISTENT REPORTING OF POSTOPERATIVE SYMPTOMS, AND UNEVEN DISTRIBUTION OF OPERATIONS AMONG SURGEONS, POTENTIALLY INTRODUCING BIAS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE." }, { "mdr_text_key": "349335039", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS MDR REFLECTS ADVERSE EVENT ONLY DATA FROM A LITERATURE ARTICLE. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. ADDITIONALLY, THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. THE DESIGNATE AUTHOR WAS CONTACTED FOR ADDITIONAL INFORMATION UNSUCCESSFULLY. CITATION: ROBOTIC HIATAL HERNIA REPAIR WITHOUT MESH. JOURNAL OF THORACIC DISEASE. SADEGHI, J. K., LI, L. T., SINGH, V. A., ZELTSMAN, D., GLASSMAN, L. R., JURADO, J. E., HYMAN, K. M., & LEE, P. C. (2024). HTTPS://DOI.ORG/10.21037/JTD-23-753. ." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }