{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2021-11222", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20210929", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "LITERATUR" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20210929", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1448814", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210929", "brand_name": "DA VINCI", "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": "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": "", "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": "", "date_changed": "20250728", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20210929", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Seroma", "Unspecified Tissue Injury", "Hemorrhage/Blood Loss/Bleeding", "Seroma", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20210903", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12551117", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210903", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "280695295", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED INCIDENTS CANNOT BE DETERMINED OR IS UNKNOWN. THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION, OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. ISI HAS ATTEMPTED TO FOLLOW-UP TO GATHER ADDITIONAL INFORMATION. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. UNABLE TO CONDUCT SITE, SYSTEM OR INSTRUMENT LOG REVIEW DUE TO LACK OF SITE, SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. WHILE THERE IS LIMITED INFORMATION ABOUT EACH EVENT IN ORDER TO PROVIDE A COMPLETE REPORT FOR EACH EVENT, AND THERE IS NO SPECIFIC ALLEGATION TO INVESTIGATE, THE EVENTS MEET THE CRITERIA OF A REPORTABLE ADVERSE EVENT AS IT WAS ALLEGED WITHIN THE CLINICAL ARTICLE THAT THERE WAS A NON-ISI PRODUCT INSERTION INJURY, TWO INTRAOPERATIVE BOWEL INJURIES WITH AN UNSPECIFIED AMOUNT OF BLEEDING, AND VARIOUS OTHER COMPLICATIONS FOR WHICH SOME REQUIRED MEDICAL INTERVENTION AND ONE REQUIRED A REOPERATION. IT IS UNKNOWN IF THE PATIENTS' COMORBIDITY/COMORBIDITIES OR ANY OTHER PRE-EXISTING CONDITIONS MAY HAVE CONTRIBUTED TO THE ALLEGED EVENTS. AT THIS TIME, THE ROOT CAUSE OF THE INTRA-OPERATIVE AND POST-OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "280695296", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 03-SEP-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE, VIA AN ISI CLINICAL JOURNAL REVIEW, OF A JOURNAL HERNIA ARTICLE TITLED ¿COMPARISON OF PERIOPERATIVE OUTCOMES BETWEEN NON-OBESE AND OBESE PATIENTS UNDERGOING ROBOTIC INGUINAL HERNIA REPAIR [RIHR]: A PROPENSITY SCORE MATCHING ANALYSIS¿ (KUDSI, O. Y., BOU-AYASH, N., ET AL., 2021). A SINGLE-CENTER, ¿TEACHING COMMUNITY HOSPITAL,¿ RETROSPECTIVE REVIEW OF COLLECTED DATA SURROUNDING RIHR PROCEDURES WAS PERFORMED WITH THE STUDY PERIOD BEING BETWEEN FEBRUARY 2013 AND AUGUST 2020. PATIENTS WERE DIVIDED INTO NON-OBESE (< 30 KG/M2) AND OBESE (= 30 KG/M2) GROUPS. OF A TOTAL OF 547 PATIENTS, 414 WERE NON-OBESE AND 133 WERE OBESE. SURGICAL TECHNIQUE: ROBOTIC TRANSABDOMINAL PRE-PERITONEAL (RTAPP) INGUINAL HERNIA REPAIR: AFTER APPROPRIATE PREPARATION, A VERESS NEEDLE [NON-ISI PRODUCT] INSERTED INTO THE LEFT UPPER QUADRANT WAS USED TO ESTABLISH PNEUMOPERITONEUM. THREE 8.5 MM TROCARS WERE INSERTED 8 CM APART AND 4 CM ABOVE THE UMBILICUS LEVEL. THE PATIENT SIDE CART OF THE DA VINCI SURGICAL ROBOTIC SYSTEM (INTUITIVE SURGICAL, SUNNYVALE, CA) WAS DOCKED. POLYESTER MESH MATERIAL WAS USED. WITHIN THE JOURNAL ARTICLE, COMPLICATIONS WERE NOTED: \"INTRA-OPERATIVE COMPLICATIONS WERE SEEN IN 1 (0.2%) NONOBESE PATIENT (VERESS INSERTION INJURY) AND 2 (1.5%) OBESE PATIENTS (SEROSAL BOWEL INJURY AND BLEEDING FROM THE INFERIOR EPIGASTRIC VESSELS).\" ADDITIONALLY, INCLUDING BOTH THE OBESE AND NON-OBESE COMPARISONS, THE JOURNAL ARTICLE CITED THE FOLLOWING POST-OPERATIVE COMPLICATIONS: TWO (0.8%) POSTOPERATIVE SEROMAS REQUIRED AN ULTRASOUND-GUIDED INTERVENTION. ONE PATIENT WITH A CHRONIC SEROMA AND ONE PATIENT WITH AN ORGANIZED HEMATOMA PERSISTING BEYOND 6 MONTHS UNDERWENT A SURGICAL PROCEDURE. TWO (0.8%) PATIENTS REQUIRED ICU FOLLOW-UP IMMEDIATELY AFTER SURGERY DUE TO HYPOTENSION AND CO2 RETENTION. THERE WERE NO HERNIA RECURRENCES WITHIN THE MEDIAN POSTOPERATIVE FOLLOW-UP PERIOD. ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }