{ "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": "2955842-2025-21555", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250530", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250103", "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", "Study", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250530", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1304000", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250530", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250826", "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": "20250530", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "62 YR", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Obstruction/Occlusion", "Bowel Perforation", "Fistula", "Obstruction/Occlusion", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20250506", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22119932", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250506", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "371449491", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF AN ARTICLE WAS CONDUCTED WHICH PROVIDED UPDATED OUTCOMES ON PREVIOUSLY REPORTED ROBOTIC REPAIRS OF PARASTOMAL HERNIAS USING A NOVEL TECHNIQUE. THE STUDY REVIEWED 26 PATIENTS WHO HAD PREVIOUSLY UNDERGONE ROBOTIC ASSISTED \"SUGARBAKER\" PARASTOMAL HERNIA REPAIR (PHR) USING MESH BETWEEN 2018 AND 2024. THE PATIENTS INCLUDED 9 FEMALES AND 17 MALES WITH A MEAN AGE OF 61.5 YEARS (58.0-67.0 YEARS) AND A MEAN BMI OF 29.5 KG/M2 (25.7-32.6 KG/M2). A TOTAL OF 3 PATIENTS EXPERIENCED COMPLICATIONS REQUIRING RE-OPERATION, INCLUDING ONE WHO DEVELOPED AN OBSTRUCTION AT THE STOMA SITE AND A CECAL PERFORATION AND REQUIRED MESH EXCISION. ANOTHER PATIENT REPORTEDLY DEVELOPED A FISTULA BETWEEN THE COLOSTOMY AND THE MESH REQUIRING MESH EXCISION AND A THIRD WHO DEVELOPED A STRICTURE AT THE PERITONEAL CLOSURE AND WAS REVISED WITHOUT FURTHER COMPLICATIONS. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT ATTRIBUTE ANY EVENTS TO A DA VINCI DEVICE, SYSTEM OR PRODUCT. THE STUDY CONCLUDED THAT THIS NOVEL TECHNIQUE FOR MINIMALLY INVASIVE PARASTOMAL HERNIA REPAIR IS EFFECTIVE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CORRESPONDENCE AUTHOR. THE CORRESPONDENCE AUTHOR INDICATED: \"THIS WAS NOT DUE TO YOUR SYSTEM\"." }, { "mdr_text_key": "371449492", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. A SYSTEM LOG REVIEW WAS NOT PERFORMED AS THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. CITATION: POLCZ, M.E., HOLLAND, A., WILEY, A. ET AL. ROBOTIC SUGARBAKER PARASTOMAL HERNIA REPAIR: UPDATED SERIES AND OUTCOMES. HERNIA 29, 61 (2025). HTTPS://DOI.ORG/10.1007/S10029-024-03227-1. PATIENT BMI REPORTED REFLECTS THE STUDY MEAN OF 29.5 KG/M2. THE BMI RANGE WAS 25.7-32.6 KG/M2. IN SECTION A2 PATIENT AGE REFLECTS THE STUDY MEAN AGE OF 62 YEARS. THE AGE RANGE WAS 58-67 YEARS. IN SECTION B3, THERE IS INSUFFICIENT INFORMATION REGARDING THE PROCEDURE DATE; THEREFORE, THE ARTICLE PUBLISH DATE WAS USED. IN SECTION D4, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS; THUS, THE PRODUCT IS REPORTED AS NOT APPLICABLE (N/A)." } ], "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": "" } ] }