{ "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": "2955842-2013-03462", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130910", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120828", "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": "20130911", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "453762", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130910", "brand_name": "DA VINCI S 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": "IS2000 A5.1P8", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20130910", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "30 YR", "patient_sex": "", "patient_weight": "54", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Pain", "No Code Available" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3340385", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "15424713", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF THIS LEGAL MEDIATION EFFORT ON (B)(6) 2013, INTUITIVE SURGICAL INC. RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS OF THIS PATIENT WHO SUFFERED POST COMPLICATIONS AFTER UNDERGOING A DA VINCI ROBOTIC S PYELOPLASTY PROCEDURE ON (B)(6) 2012. THE PATIENT CAME TO THE SURGERY OFFICE ON (B)(6) 2012 WITH THE COMPLAINT OF LEFT-SIDED FLANK PAIN AND PRESSURE. THE CT SCAN SHOWED LEFT SIDED HYDRONEPHROSIS AND QUESTIONABLE CROSSING VESSEL. THE PATIENT DECIDED TO PROCEED WITH ROBOT-ASSISTED PYELOPLASTY AFTER THE SURGEON EXPLAINED THE RISK OF THE PROCEDURE AND THE POSSIBILITY THAT THE SYMPTOM MAY NOT BE RESOLVED BY THE PROCEDURE. PER THE MEDICAL RECORDS, THE ROBOTIC ASSISTED PYELOPLASTY PROCEDURE ON (B)(6) 2012 WAS SUCCESSFUL. THE PATIENT HAD AN UNEVENTFUL POST-OP COURSE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THERE IS NO EVIDENCE IN THE MEDICAL RECORDS THAT THE DA VINCI S SYSTEM MALFUNCTIONED. ON (B)(6) 2012, THE PATIENT WAS ADMITTED DUE TO THE PATIENT'S COMPLAINT OF SEVERE LEFT FLANK PAIN. CT SCAN FOUND A URINARY LEAK AT THE ANASTOMOTIC SITE AND HYDRONEPHROSIS. HIS PAIN WORSENED AFTER IV FLUIDS STARTED. A CATHETER WAS PLACED WITH THE AIM OF IMPROVING RENAL DEPRESSION, BUT THE FLANK PAIN AND LOWER QUADRANT WAS NOT IMPROVED. ON (B)(6) 2012,THE PATIENT WAS TAKEN TO OR FOR PLACEMENT OF A PERCUTANEOUS NEPHROSTOMY TUBE WHICH BROUGHT IMMEDIATE RELIEF OF HIS PAIN. PATIENT WAS DISCHARGED ON (B)(6) 2012, WITH MINIMAL PAIN AND WAS PRESCRIBED PAIN MEDICATION. ON (B)(6) 2012, THE PATIENT'S FOLLOW-UP VISIT RECORDS SHOWED THAT THE PATIENT WAS DOING WELL. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CURRENT STATUS." }, { "mdr_text_key": "15664659", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ANY ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE OPERATIVE REPORT DOES NOT HAVE ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. INTUITIVE SURGICAL HAS MADE AN ATTEMPT TO CONTACT THE SITE TO OBTAIN FURTHER CLINICAL INFORMATION; HOWEVER, AS OF DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL PYELOPLASTY PROCEDURE. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT." } ], "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": "" } ] }