{ "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": "2955842-2015-00059", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150109", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130625", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150112", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "23307", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150109", "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", "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": [ "Unexpected Therapeutic Results" ], "reporter_state_code": "NJ", "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": "20150109", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "67 YR", "patient_sex": "", "patient_weight": "73", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Scarring", "Therapeutic Effects, Unexpected", "Tissue Damage", "Numbness", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20141213", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4405375", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141213", "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": "20777398", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE SURGEON CUT ONE OR MORE UNSPECIFIED ARTERIES WHILE ATTEMPTING TO REMOVE LYMPH NODES. ACCORDING TO THE PATIENT, AFTER THE UTERUS, OVARIES, AND FALLOPIAN TUBES WERE REMOVED, THE SURGEON WENT BACK IN TO REMOVE THE LYMPH NODES ON THE RIGHT SIDE. THE PATIENT STATED THAT AS THE LYMPH NODES WERE BEING REMOVED, ARTERIES ATTACHED TO THE LYMPH NODES WERE CUT IN TWO UNSPECIFIED PLACES. A TOTAL OF 14 LYMPH NODES WERE REMOVED. THE SURGEON ATTEMPTED UNSUCCESSFULLY TO REPAIR THE ARTERIES USING THE DA VINCI SURGICAL SYSTEM. A VASCULAR SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY IN ORDER TO REPAIR THE VESSELS. A BLOOD TRANSFUSION WAS ADMINISTERED AND 4 UNITS OF BLOOD WERE GIVEN. THE SURGICAL PROCEDURE TOOK 10 HOURS TO COMPLETE. THE PATIENT INDICATED THAT SHE WAS IN THE ICU FOR EIGHT DAYS POST-OPERATIVELY. IV FLUIDS WERE ADMINISTERED WHICH CAUSED SEVERE BLOATING. AN UNSPECIFIED MEDICATION WAS THEN ADMINISTERED TO ASSIST THE PATIENT WITH FLUID ELIMINATION TO MINIMIZE THE BLOATING. AT AN UNSPECIFIED TIME POST-OPERATIVELY, THE PATIENT INDICATED THAT SHE WENT INTO ATRIAL FIBRILLATION. UPON DISCHARGE FROM THE HOSPITAL, THE PATIENT WAS PRESCRIBED DAILY BLOOD THINNER INJECTIONS FOR APPROXIMATELY 2 MONTHS. THE PATIENT STATED THAT SHE CURRENTLY HAS SWELLING IN HER RIGHT LEG FROM THE REMOVAL OF HER LYMPH NODES. SHE ALSO STATED THAT HER SCARRING IS PAINFUL AND SHE EXPERIENCES NUMBNESS ON THE OUTSIDE OF HER LEG BETWEEN THE HIP AND KNEE. SHE ALSO SUFFERS FROM DEPRESSION AND WEEPINESS. THERE WAS NO CLAIM BY THE PATIENT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "20845880", "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 INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. 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 SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. MULTIPLE SYSTEM ERROR 32003 CODES WERE GENERATED DURING THE 8 HOUR SURGICAL PROCEDURE. A SYSTEM ERROR 32003 CODE SIGNIFIES THAT THE VESSEL SEALER INSTRUMENT WAS NOT ABLE TO DRIVE THE CUTTING BLADE ACROSS THE FULL RANGE OF TRAVEL DURING A CUT COMMAND. THIS COULD BE CAUSED BY A DIRTY VESSEL SEALER INSTRUMENT OR ATTEMPTS BY THE SURGEON TO CUT VERY THICK AND/OR UNSEALED TISSUE. NO OTHER RELATED SYSTEM ERROR CODES WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S REPORTED VESSEL INJURIES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE SUSTAINED VESSEL INJURIES THAT REQUIRED REPAIR BY A VASCULAR SURGEON WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE INJURIES IS UNKNOWN." } ], "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": "" } ] }