{ "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": "2955842-2013-04017", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131004", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100602", "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": "20131007", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "502863", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131004", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20131004", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "111", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Edema", "Muscle Weakness/Atrophy", "Pain", "Ambulation or Postural Difficulties" ] } ], "distributor_city": "", "date_report": "20130905", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3388791", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130905", "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": "3800205", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON SEPTEMBER 5, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, OMENTAL BIOPSY, AND BILATERAL PELVIC LYMPHADENECTOMY ON (B)(6) 2010. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF BIOPSY-PROVEN GRADE I ENDOMETRIAL CARCINOMA (ENDOMETRIOID TYPE) AND MORBID CENTRAL OBESITY ((B)(6)). DURING A PRE-OPERATIVE CONSULTATION ON (B)(6) 2010, THE PATIENT WAS INFORMED OF THE RISKS, BENEFITS, AND ALTERNATIVES OF LAPAROTOMY VERSUS MINIMALLY INVASIVE TECHNIQUE. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI SI SURGICAL PROCEDURES ON (B)(6) 2010 WERE COMPLETED WITH ADDED COMPLEXITY DUE TO THE PATIENT'S MORBID CENTRAL OBESITY. DURING THE BILATERAL STAGING PELVIC LYMPHADENECTOMY, DISSECTION WAS CARRIED OUT INFERIORLY TO THE BORDER OF THE OBTURATOR NERVE. THE SURGEON STATED IN THE OPERATIVE NOTE THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO REPORTED MALFUNCTIONS OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE PROCEDURES. THE PATIENT WAS DISCHARGED HOME ON POST-OPERATIVE DAY 1 AFTER SHE WAS ABLE TO VOID, AMBULATE, TOLERATE A REGULAR DIET, AND HER PAIN WAS WELL CONTROLLED WITH ORAL PAIN MEDICATIONS. ACCORDING TO A PHYSICIAN'S NOTE FROM (B)(6) 2010, THE PATIENT WAS DOING WELL SINCE SURGERY AND HAD NO COMPLAINTS DURING A POST-OPERATIVE VISIT. BASED ON PHYSICIAN NOTES FROM (B)(6) 2010, AND (B)(6) 2011, THE PATIENT WAS EVALUATED POST-OPERATIVELY FOR SEVERE RIGHT LEG PAIN, LEG EDEMA, AND LYMPHEDEMA. IN ADDITION, IT WAS REPORTED THAT THE PATIENT COULD NOT ADDUCT HER LEG. THE PATIENT WAS ENCOURAGED TO DO PHYSICAL THERAPY. ACCORDING TO THE PHYSICIAN'S NOTE FROM (B)(6) 2010, THE PATIENT NODUAL SURVEY, AND ABDOMINAL AND PELVIC EXAMINATIONS WERE NORMAL. AN MRI OF THE PATIENT'S BRAIN WAS ALSO PERFORMED ON (B)(6) 2010 TO EVALUATE FOR A POSSIBLE STROKE IN RELATION TO REPORTED COMPLAINTS OF RIGHT LEG WEAKNESS AND DIFFICULTY WALKING. THE MRI DID NOT REVEAL ANY EVIDENCE OF AN ACUTE STROKE OR ACUTE PARENCHYMAL BRAIN ABNORMALITY. ON (B)(6) 2012, AN MRI OF THE PATIENT'S PELVIS WAS PERFORMED DUE TO REPORTED COMPLAINTS OF RIGHT LEG WEAKNESS AND INSTABILITY. THE MRI REVEALED MARKED FATTY ATROPHY OF THE RIGHT ABDUCTOR MUSCLES, PSOAS MUSCLE, AND OBTURATOR MUSCLES. THERE WAS NO VISUAL EVIDENCE OF A MASS OR SIGNAL ABNORMALITY ALONG THE EXPECTED COURSE OF THE OBTURATOR NERVE. NO ADDITIONAL MEDICAL RECORDS AFTER (B)(6) 2012 WERE PROVIDED IN RELATION TO THE PATIENT'S REPORTED COMPLAINTS OF LEG PAIN AND EDEMA." }, { "mdr_text_key": "11220950", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE 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. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2010. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE." } ], "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": "" } ] }