{ "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": "2955842-2014-03164", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20140522", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140417", "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": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140523", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "306070", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140522", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20140522", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "73", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20140422", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3828320", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140422", "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": "4496603", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4), WITH THE FOLLOWING INFORMATION: DURING ROBOTIC LYMPH NODE DISSECTION, THE PHYSICIAN CUT THE LEFT URETER. THE UROLOGIST ON CALL FIXED THE URETER FOLLOWING ORIGINAL PROCEDURE ROBOTICALLY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON WAS DISSECTING THE GOOD PERITONEUM AND SKELETONIZING THE NODAL BUNDLE WHEN THE INJURY OCCURRED TO A PATIENT. IT IS UNKNOWN HOW LONG THE PROCEDURE WAS IN PROGRESS WHEN THE INJURY OCCURRED TO THE PATIENT. THE INITIAL REPORTER WAS UNABLE TO PROVIDE THE SURGEON'S BELIEF AS TO WHAT CAUSED OR CONTRIBUTED TO THE URETERAL INJURY. THE UROLOGIST USED 4 LATERAL STITCHES TO REPAIR THE INJURY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT HAS NOT RETURNED BACK TO THE HOSPITAL DUE TO THE REPORTED INJURY. THE INITIAL REPORTER WAS UNABLE TO PROVIDE ISI ANY FURTHER ADDITIONAL INFORMATION REGARDING THIS CASE." }, { "mdr_text_key": "11893319", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED AT THIS TIME. THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. 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) 2012 AND NO SYSTEM MALFUNCTION WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A ROBOTIC LYMPH NODE DISSECTION, THE PHYSICIAN CUT THE LEFT URETER AND THE INJURY HAD TO BE REPAIRED. HOWEVER, THE CAUSE OF THE PATIENT URETERAL INJURY IS UNKNOWN. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "18862288", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT DUE TO THE FOLLOWING CONCLUSION: DURING A ROBOTIC LYMPH NODE DISSECTION, THE PHYSICIAN CUT THE LEFT URETER AND THE INJURY HAD TO BE REPAIRED. HOWEVER, THE CAUSE OF THE PATIENT URETERAL INJURY 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": "05/29/2014" } ] }