{ "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": "2955842-2016-00731", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20161012", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20160901", "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 REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20161012", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "676180", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20161012", "brand_name": "DA VINCI XI 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": "IS4000 A7.0P5C", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20161012", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " O", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Injury", "Tissue Damage", "Injury" ] } ], "distributor_city": "", "date_report": "20160915", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6025028", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160915", "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": "57246559", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI ASSISTED HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S URETER WAS DAMAGED, REQUIRING THE PATIENT TO UNDERGO SUBSEQUENT SURGICAL PROCEDURES TO REPAIR THE DAMAGE. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2016 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT." }, { "mdr_text_key": "57246560", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A DA VINCI ASSISTED HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S URETER WAS CUT. THE PATIENT UNDERWENT 2 SUBSEQUENT SURGICAL PROCEDURES AND IS GOING TO UNDERGO A 3RD PROCEDURE TO REPAIR THE DAMAGE TO HER URETER. IT WAS ALSO REPORTED THAT THE PATIENT HAS A BAG. ON (B)(6) 2016 INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION FROM THE PATIENT REGARDING THE REPORTED EVENT. ACCORDING TO THE PATIENT, SHE UNDERWENT THE PLANNED SURGICAL PROCEDURE ON (B)(6) 2016 AND WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON POST-OP DAY 3 SHE PRESENTED TO THE HOSPITAL'S EMERGENCY ROOM DEPARTMENT AND IT WAS DISCOVERED THAT HER URETER WAS CUT. ACCORDING TO THE PATIENT, THE DAMAGE TO HER URETER PREVENTED HER KIDNEY FROM DRAINING. IN ADDITION TO UNDERGOING TWO SUBSEQUENT LAPAROSCOPIC PROCEDURES TO RESOLVE THE DRAINAGE ISSUE SHE CURRENTLY HAS A TEMPORARY UROSTOMY BAG. SHE IS EXPECTED TO UNDERGO THE 3RD SURGICAL PROCEDURE TO REPAIR HER URETER IN APPROXIMATELY 1 MONTH. ACCORDING TO THE PATIENT, THERE WAS NO REPORT TO HER BY THE HOSPITAL THAT ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM AND/OR INSTRUMENTS OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT INDICATED THAT SHE WAS TOLD BY HER SURGEON THAT THE INJURY TO HER URETER WAS DUE TO HIS SURGICAL TECHNIQUE. ACCORDING TO THE PATIENT, THE SURGEON SPECULATED THAT THE DAMAGE TO HER URETER OCCURRED DURING SUTURE TO PREVENT HER FROM DEVELOPING PROLAPSE AND HE MAY HAVE INADVERTENTLY PLACED STITCHES IN HER URETER. THE PATIENT INDICATED THAT SHE IS FEELING OK, SHE HAS NO COMPLAINT AGAINST THE SURGEON OR THE DA VINCI SURGICAL SYSTEM AND THAT THE DAMAGE TO HER URETER WAS A FLUKE." } ], "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": "" } ] }