{ "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": "2955842-2025-14812", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250422", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20241129", "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": "20250422", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1888269", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250422", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "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": "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": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250422", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "64 YR", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Urinary Retention", "Hernia", "Urinary Retention", "Hernia" ] } ], "distributor_city": "", "date_report": "20250325", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21883813", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250325", "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": "368660774", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE TITLED, \"INCIDENCE OF INCISIONAL HERNIAS AFTER SINGLE-PORT VERSUS MULTI-PORT ROBOTIC-ASSISTED RADICAL PROSTATECTOMY,\" WAS PERFORMED. A TOTAL OF 493 PATIENTS UNDERWENT PRIMARY RARP WITH OR WITHOUT CONCOMITANT BILATERAL PELVIC LYMPH NODE DISSECTION VIA A TRANSPERITONEAL APPROACH. IN THE STUDY, 320 OF THESE PATIENTS UNDERWENT SINGLE-PORT ROBOTIC-ASSISTED RADICAL PROSTATECTOMY (SP-RARP) AND 173 UNDERWENT MULTI-PORT RARP (MP-RARP). THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, MULTIPLE HERNIAS WERE REPORTED IN THE SP-RARP GROUP. TWENTY-SIX OF THESE PATIENTS DEVELOPED INCISIONAL HERNIAS (IH). ALL 26 PATIENTS, EXCEPT FOR TWO, WERE SYMPTOMATIC OR DIAGNOSED VIA PHYSICAL EXAMINATION DURING ROUTINE FOLLOW-UP. TWO OF THE PATIENTS UNDERWENT CT IMAGING IN THE EMERGENCY ROOM: ONE FOR ACUTE URINARY RETENTION WITH AN OBSTRUCTED FOLEY CATHETER AND ONE FOR A SYMPTOMATIC INCARCERATED HERNIA. OF THE 26 SP-RARP HERNIA PATIENTS, 10 REQUIRED SURGICAL REPAIR WITH MESH. THE STUDY CONCLUDED THAT PATIENTS WITH HIGHER BMIS AND PRIOR HISTORY OF ABDOMINAL SURGERIES ARE AT INCREASED RISK OF DEVELOPING POSTOPERATIVE INCISIONAL HERNIAS. SP-RARP PROCEDURES APPEAR TO HAVE A HIGHER RISK OF POSTOPERATIVE INCISIONAL HERNIAS. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR THE AUTHOR ALLEGED THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "368660775", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: RAIS-BAHRAMI, S., MD, ET AL., INCIDENCE OF INCISIONAL HERNIAS AFTER SINGLE-PORT VERSUS MULTI-PORT ROBOTIC RADICAL PROSTATECTOMY. HTTPS://DOI: 10.1089/END.2024.0367 FIELD B3: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED DATE HAS BEEN USED." } ], "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": "" } ] }