{ "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": "2955842-2013-01333", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130419", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120920", "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": "20130422", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "169909", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130419", "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 A60.P8", "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" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20130419", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Renal Failure" ] } ], "distributor_city": "", "date_report": "20130320", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3068979", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130320", "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": "3264784", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, ISI RECEIVED A LEGAL COMPLAINT ALLEGING THAT A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AT (B)(6), EXPERIENCED POST-OPERATIVE COMPLICATIONS OF BILATERAL RENAL OBSTRUCTION AND ACUTE RENAL FAILURE." }, { "mdr_text_key": "10733254", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A REVIEW OF THE PATIENT'S MEDICAL RECORDS INDICATED THAT THE PATIENT UNDERWENT A ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS PELVIC PAIN AND MENOMETRORRHAGIA. THE PATIENT'S OPERATIVE REPORT INDICATED THAT HER URINE WAS CLEAR AT THE END OF THE PROCEDURE AND SHE TOLERATED THE PROCEDURE WELL AND WENT TO RECOVERY IN SATISFACTORY CONDITION. THERE WAS NO INDICATION IN THE OPERATIVE REPORT THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 IN GOOD CONDITION ACCORDING TO THE PATIENT'S DISCHARGE SUMMARY REPORT. THE PATIENT'S DISCHARGE SUMMARY REPORT INDICATED THAT SHE UNDERWENT A ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY UNDER GENERAL ANESTHESIA WITHOUT COMPLICATIONS. THE DISCHARGE SUMMARY REPORT ALSO INDICATED THE PATIENT WAS AMBULATING WELL, VOIDING WELL, AFEBRILE. THE PATIENT'S MEDICAL RECORDS INDICATE THAT ON (B)(6) 2012, SHE WAS ADMITTED TO THE HOSPITAL'S EMERGENCY ROOM (ER) WITH A COMPLAINT OF ANURIA AND A DIAGNOSIS OF ACUTE RENAL FAILURE AND BILATERAL RENAL OBSTRUCTION. A CT SCAN PERFORMED THAT SAME DAY SHOWED BILATERAL HYDRONEPHROSIS. ON (B)(6) 2012, THE PATIENT UNDERWENT PLACEMENT OF BILATERAL PERCUTANEOUS NEPHROSTOMY TUBES. THE OPERATIVE REPORT INDICATED THAT THE PATIENT'S RENAL FAILURE QUICKLY RESOLVED AND SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT'S MEDICAL RECORDS INDICATED THAT ON (B)(6) 2012, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH A COMPLAINT OF NO DRAINAGE FROM HER RIGHT KIDNEY. A NEPHROSTOGRAM PERFORMED ON THE PATIENT REVEALED THAT THE NEPHROSTOMY TUBE WAS NO LONGER IN THE KIDNEY. THE NEPHROSTOMY TUBE WAS REPLACED AND SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT'S MEDICAL RECORD INDICATED THAT SHE WAS SCHEDULED TO UNDERGO BILATERAL URETERAL REIMPLANTS. ON (B)(4) 2013, ISI CONTACTED THE CORPORATE DIRECTOR OF RISK MANAGEMENT FOR THE HOSPITAL TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE CORPORATE DIRECTOR OF RISK MANAGEMENT INDICATED THAT NO MALFUNCTION OF THE DA VINCI SI SYSTEM, INSTRUMENTS, AND ACCESSORIES DURING THE HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2012, WAS REPORTED TO HIM BY THE SURGICAL STAFF. HE INDICATED THAT THE SURGICAL PROCEDURE WAS NOT RECORDED. HE INDICATED THAT HE WAS UNABLE TO GIVE A POSSIBLE CAUSE OF THE PATIENT'S REPORTED INJURIES AND THAT HE WAS UNABLE TO PROVIDE ANY ADDITIONAL CLINICAL INFORMATION REGARDING THE REPORTED EVENTS. ISI'S REVIEW OF THE SITE'S SYSTEM LOG FOR (B)(6) 2012, REVEALED TWO SURGICAL PROCEDURES THAT WERE NOT PERFORMED BY THE SURGEON INVOLVED WITH THIS COMPLAINT. HOWEVER, THE SITE'S SYSTEM LOG REVEALED THAT ON (B)(6) 2012, A HYSTERECTOMY PROCEDURE WAS PERFORMED BY THE SURGEON INVOLVED IN THIS COMPLAINT AND THERE WERE NO OCCURRENCES OF ANY SYSTEM ERRORS THAT CAUSED OR CONTRIBUTED THE ALLEGED INJURIES SUSTAINED 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": "" } ] }