{ "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": "HOSPITAL", "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": "2955842-2015-00754", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150515", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Foreign", "Literature", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150518", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "318982", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150515", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "", "catalog_number": "", "lot_number": "", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20150515", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Injury" ] } ], "distributor_city": "", "date_report": "20150420", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4775651", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150420", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "16362400", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE FOLLOWING INFORMATION IS UNKNOWN: THE NAME OF THE HOSPITAL WHERE THE ROBOTIC SURGERY WAS PERFORMED, THE NAME OF THE SURGEON WHO PERFORMED THE SURGERY, AND THE DATE OF THE SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE ARTICLE'S CORRESPONDENCE CONTACT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ACCORDING TO THE ARTICLE, A PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "15903133", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A CLINICAL STUDY ARTICLE TITLED, IMPLEMENTATION OF A ROBOTIC SURGICAL PROGRAM IN GYNAECOLOGICAL ONCOLOGY AND COMPARISON WITH PRIOR LAPAROSCOPIC SERIES. (INTERNATIONAL JOURNAL OF SURGICAL ONCOLOGY: VOL. 2015, ARTICLE ID 814315). ACCORDING TO THE ARTICLE, THE AIM OF THE STUDY WAS TO DETERMINE WHETHER ROBOTIC SURGERY DURING THE LEARNING CURVE OF THE TEAM HAS COMPARABLE PARAMETERS OF TIME AND MORBIDITY WHEN COMPARED TO WELL-ESTABLISHED LAPAROSCOPIC APPROACH. WITHIN THE ARTICLE, IT IS STATED, FURTHERMORE, A KNOWN IMMUNOCOMPROMISED PATIENT WHO HAD RH + BPLND PRESENTED WITH A RETROPERITONEAL ABSCESS ON DAY 15 AFTER SURGERY. SHE HAD A PROTRACTED COURSE ORIGINALLY MANAGED WITH ANTIBIOTICS FOLLOWED BY BILATERAL RADIOLOGICAL DRAINAGE AFTER WHICH BOWEL INJURY WAS NOTED IN THE CAECUM AND DESCENDING COLON. THAT LED TO RETURN TO THEATRE FOR A LAPAROSCOPIC ILEOSTOMY. THE PATIENT SUBSEQUENTLY RECOVERED WELL. NO FURTHER DETAILS REGARDING THE PATIENT OR SURGICAL PROCEDURE WERE PROVIDED IN THE ARTICLE." } ], "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": "" } ] }