{ "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": "2955842-2013-01334", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130419", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120831", "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": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130422", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "168955", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130419", "brand_name": "DA VINCI SI 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": "IS3000 A6.0P8", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20130419", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "44 YR", "patient_sex": "", "patient_weight": "111", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Chest Pain", "Dyspnea", "Fever", "Pleural Effusion", "Respiratory Tract Infection" ] } ], "distributor_city": "", "date_report": "20130320", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3069004", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130320", "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": "3426364", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, ISI RECEIVED A LEGAL COMPLAINT ALLEGING THAT A PATIENT WHO UNDERWENT A DA VINCI SI MYOMECTOMY PROCEDURE ON (B)(6) 2012 AT (B)(6) DEVELOPED POST-SURGICAL SYMPTOMS OF CHEST PAIN, DYSPNEA, ABDOMINAL PAIN, AND INTRA-ABDOMINAL PELVIC ABSCESSES. THE LEGAL COMPLAINT ALLEGES THAT THE PATIENT DEVELOPED CHEST PAIN POST-OPERATIVELY ON (B)(6) 2012. ALLEGEDLY, OXYGEN WAS ADMINISTERED TO THE PATIENT AND THE PATIENT'S CHEST PAIN WAS RELIEVED SPONTANEOUSLY AFTER 30 MINUTES. THE LEGAL COMPLAINT ALLEGES THAT ON (B)(6) 2012 A CHEST CT ANGIOGRAM (CTA) PERFORMED ON THE PATIENT SHOWED NO EVIDENCE OF PULMONARY EMBOLUS AND THAT SAME DAY THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2012, THE PATIENT ALLEGEDLY DEVELOPED SHORTNESS OF BREATH (SOB), CHEST PAIN, AND ABDOMINAL PAIN AND ON (B)(6) 2012, THE PATIENT WAS ADMITTED INTO THE HOSPITAL'S EMERGENCY ROOM DUE TO WORSENING SYMPTOMS OF SOB. ALLEGEDLY A CHEST X-RAY PERFORMED SHOWED THAT THE PATIENT HAD SMALL PLEURAL EFFUSIONS WITH ASSOCIATED ATELECTASIS. THE PATIENT WAS TREATED FOR A POSSIBLE RESPIRATORY TRACT INFECTION. ON (B)(6) 2012, THE PATIENT ALLEGEDLY DEVELOPED A RECURRENT FEVER AND ON (B)(6) 2012, AN ABDOMINAL CT PERFORMED ON THE PATIENT SHOWED THAT THE PATIENT HAD MULTIPLE INTRA-ABDOMINAL AND PELVIC ABSCESSES. ON (B)(6) 2012, THE PATIENT UNDERWENT A CT-GUIDED DRAINAGE FOR 3 OF THE ABSCESSES. ALLEGEDLY, DUE TO THE PATIENT'S RECURRENT FEVER, ON (B)(6) 2012, ANOTHER CT WAS PERFORMED ON THE PATIENT. THE CT SCAN SHOWED THAT THE PATIENT HAD PERSISTENT FLUID COLLECTIONS. THE LEGAL COMPLAINT ALLEGES THAT ON (B)(6) 2012, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION, LYSIS OF ADHESIONS, AND PLACEMENT OF JACKSON-PRATT DRAINS. THE PATIENT WAS ADMITTED INTO THE ICU POST-OPERATIVELY AND WAS THEN TRANSFERRED TO THE REGULAR FLOOR ON (B)(6) 2012. ALLEGEDLY, 14 DAYS POST OPERATIVELY, THE PATIENT REMAINED STABLE AND AFEBRILE. ON AN UNSPECIFIED DATE/TIME, THE PATIENT WAS DISCHARGED TO AN ACUTE CARE NURSING FACILITY ON A FULL LIQUID DIET AND ANTIBIOTIC THERAPY." }, { "mdr_text_key": "10727200", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, ISI CONTACTED THE RISK MANAGER AT THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE RISK MANAGER DECLINED TO PROVIDE ANY INFORMATION REGARDING THE PATIENT OR DETAILS OF THE REPORTED EVENTS. HOWEVER, THE RISK MANAGER INDICATED THAT THERE WERE NO REPORTS BY THE SURGICAL STAFF OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES DURING THE MYOMECTOMY PROCEDURE PERFORMED ON (B)(6) 2012. A REVIEW OF THE PATIENT'S OPERATIVE REPORT FOR THE DA VINCI SI MYOMECTOMY PROCEDURE PERFORMED ON (B)(6) 2012 DID NOT INDICATE THAT THE PATIENT EXPERIENCED ANY COMPLICATIONS DURING THE SURGICAL PROCEDURE. THE PATIENT'S OPERATIVE REPORT INDICATED THAT FRAGMENTS OF ALL THE FIBROIDS WERE REMOVED, THE PELVIS WAS THOROUGHLY IRRIGATED, ALL DEBRIS WAS REMOVED, AND GOOD HEMOSTASIS WAS NOTED. THE DISPOSITION ON THE OPERATIVE REPORT NOTED THAT THE PATIENT WAS EXTUBATED AND SENT TO THE RECOVERY ROOM IN STABLE CONDITION. THREE SEPARATE SURGERIES WERE PERFORMED ON THE SYSTEM ON THE SAME DAY, AND INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE WHICH LOG APPLIES TO THIS EVENT, ALTHOUGH NO ERRORS IN FUNCTION WERE NOTED IN ALL LOGS FOR THAT DAY." } ], "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": "" } ] }