{ "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": "2955842-2014-01385", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20140307", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110310", "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": "20140307", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "138863", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140307", "brand_name": "DA VINCI S 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": "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": [ "Defective Component" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20140307", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "54", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Nausea", "Pain", "Vomiting", "Injury" ] } ], "distributor_city": "", "date_report": "20131218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3667711", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131218", "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": "11691178", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND THE CUSTOMER REPORTED FAILURE MODE THAT A SPARK WAS OBSERVED DURING THE SURGICAL PROCEDURE. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI SURGICAL PROCEDURE, A SPARK WAS OBSERVED AND THE PATIENT SUSTAINED A URETEROTOMY. HOWEVER, AT THIS TIME, THE CAUSE OF THE SPARK AND THE PATIENT'S URETERAL INJURY ARE UNKNOWN." }, { "mdr_text_key": "4201720", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI TOTAL HYSTERECTOMY AND RIGHT SALPINGECTOMY FOR PELVIC PAIN, ABNORMAL UTERINE BLEEDING, UTERINE FIBROIDS, AND RIGHT HYDROSALPINX ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ACCORDING TO THE OPERATIVE REPORT, THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION OF A RIGHT URETERAL INJURY. AFTER RELEASE OF THE V RING OF THE VCARE UTERINE MANIPULATOR, THERE WAS NOTED TO BE A PERFORATING BLEEDING VESSEL THAT APPEARED TO BE PART OF THE DESCENDING BRANCHES OF THE UTERINE ARTERY. THE SURGEON REPORTS, UPON DESICCATING THAT A SPARK WAS NOTED TO SPARK TO THE RIGHT URETER AND A PINPOINT HOLE WAS NOTED IN THE RIGHT URETER. UROLOGY WAS CALLED IN TO THE OPERATING ROOM TO CONSULT AND REPAIR THE URETEROTOMY DEFECT. ACCORDING TO THE UROLOGIST'S NOTES, THE AREA OF INJURY WAS CONSISTENT WITH A THERMAL INJURY. THE UROLOGIST PERFORMED A CYSTOSCOPY, ROBOTIC-ASSISTED RIGHT URETERAL REIMPLANTATION AND PLACEMENT OF A DOUBLE-J STENT. THE REMAINDER OF THE HYSTERECTOMY PROCEDURE WAS PERFORMED WITHOUT INCIDENT. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION, AND WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE JP DRAIN WAS REMOVED ON (B)(6) 2011 BUT THE FOLEY CATHETER REMAINED IN PLACE. SHE WAS DISCHARGED HOME THE FOLLOWING DAY ON (B)(6) 2011. ON (B)(6) 2011, THE URETERAL STENT WAS REMOVED AND SHE WAS STARTED ON SEPTRA AND PERCOCET. THE PATIENT LATER PRESENTED TO THE EMERGENCY ROOM (ER) WITH NAUSEA, VOMITING, AND PAIN IN HER BACK AND ABDOMEN. SHE WAS DIAGNOSED WITH HAVING AN ALLERGIC REACTION TO SEPTRA AND WAS DISCHARGED HOM ON (B)(6) 2011." } ], "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": "" } ] }