{ "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": "2955842-2013-05003", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131102", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20090707", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "565254", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131102", "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": "DA", "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": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20131102", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "56 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Respiratory Distress", "Injury", "Fluid Discharge" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444682", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140505", "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": "3901545", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI ROBOTIC HYSTERECTOMY WITH BSO AND LYMPHADENECTOMY. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HISTORY AND PHYSICAL, FOLLOW-UP OPERATIVE REPORTS, CONSULTATIONS, RADIOLOGY REPORTS, DISCHARGE SUMMARY, LAB REPORTS, PATHOLOGY REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION NAMELY INJURY TO THE LEFT URETER WHILE TRYING TO EXCISE CANCER. IT WAS REPAIRED AT THE TIME OF THE INITIAL OPERATION. ON (B)(6) 2009 - UNDERWENT ROBOTIC TOTAL HYSTERECTOMY, BSO, PELVIC LYMPHADENECTOMY, PELVIC WASHINGS AND STAGING AND LEFT URETERO-URETERO ANASTOMOSIS WITH STENT PLACEMENT. NOTED SIGNIFICANT ADHESIONS IN SURGERY AND INJURY NOTED AT LEFT URETER DURING PROCEDURE AND REPAIRED THEN. RIGHT URETER NOT DAMAGED. RETURNED TO SURGERY ON (B)(6) 2009 FOR URINE LEAKAGE AND PINPOINT OPENING NOTED LEFT URETER AND SUTURED CLOSED. THE RIGHT URETER WAS OPENED AND A RIGHT URETERAL STENT WAS PLACED. SUBSEQUENTLY SHE DEVELOPED RESPIRATORY DISTRESS FROM FLUID OVERLOAD AND WAS PLACED ON VENTILATOR. DISCHARGED HOME ON (B)(6) 2009 NO OTHER DETAILS WERE PROVIDED." }, { "mdr_text_key": "11246753", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. 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: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "19049754", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION FROM THE SITE'S ROBOTICS CLINICAL LEAD REGARDING THE REPORTED EVENT. IT WAS REPORTED THAT DURING THE INITIAL DA VINCI SURGICAL PROCEDURE ON (B)(6) 2009, THE PATIENT'S BLADDER WAS ACCIDENTALLY NICKED BY THE SURGEON DUE TO A LARGE TUMOR ON THE BLADDER NECK AND THE PATIENT'S COMPLICATIONS HAD NOTHING DO WITH THE ROBOT. SHE INDICATED THAT THE SITE HAS NO KNOWLEDGE OF ANY DA VINCI SURGICAL SYSTEM MALFUNCTIONS THAT OCCURRED DURING THE REPORTED EVENT AND THAT THE DA VINCI SURGICAL SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S REPORTED POST-OPERATIVE COMPLICATIONS. BASED ON THE ADDITIONAL INFORMATION FROM THE SITE, THERE WAS NO ALLEGATION OF A DA VINCI SURGICAL SYSTEM MALFUNCTION OR THAT THE DA VINCI SURGICAL SYSTEM CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS. THIS COMPLAINT IS STILL BEING REPORTED BASED ON THE INITIAL COMPLAINT FROM THE PLAINTIFF'S ATTORNEY, WHICH ALLEGES THAT THE PATIENT ALLEGEDLY EXPERIENCED POST-SURGICAL COMPLICATIONS FOLLOWING THE DA VINCI HYSTERECTOMY SURGERY." } ], "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": "05/09/2014" } ] }