{ "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": "2955842-2013-01332", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130419", "manufacturer_address_2": "", "pma_pmn_number": "K043153", "date_of_event": "20120806", "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": "169914", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130419", "brand_name": "DA VINCI 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": "IS1200 A43.P9", "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": "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": "20130419", "sequence_number_treatment": [ "DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "35 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Anemia", "Fever", "Laceration(s)", "Nausea", "Swelling", "Abdominal Distention" ] } ], "distributor_city": "", "date_report": "20130320", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3068994", "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": "3265306", "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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AT (B)(6), DEVELOPED POST-SURGICAL SYMPTOMS OF ABDOMINAL PAIN AND DISTENTION, SOFT TISSUE SWELLING IN THE LOWER ABDOMEN AND LABIAL AREA, ANEMIA, NAUSEA, AND FEVER. THE LEGAL COMPLAINT ALSO ALLEGES THAT THE PATIENT WAS READMITTED TO THE HOSPITAL POST-OPERATIVELY FROM ROBOTIC SURGERY FOR REPAIR OF A BLADDER LACERATION ON (B)(6) 2012." }, { "mdr_text_key": "10719297", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A REVIEW OF THE PATIENT'S OPERATIVE REPORT FOR THE DA VINCI HYSTERECTOMY PERFORMED ON (B)(6) 2012, INDICATED THAT DURING THE SURGICAL PROCEDURE THE POWER WAS LOST TWICE WITH PROMPT RETURN OF GENERATOR POWER AND BATTERY-OPERATED POWER WITH THE ROBOT WITH NO COMPROMISE TO THE SURGICAL FIELD OR THE PATIENT. THE OPERATIVE REPORT ALSO INDICATED THAT AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. A REVIEW OF THE PATIENT'S MEDICAL RECORDS INDICATED THAT A CT SCAN WAS PERFORMED ON THE PATIENT ON (B)(6) 2012, AND IT WAS DISCOVERED THAT THE PATIENT SUSTAINED A PROBABLE BLADDER LACERATION WITH INTRA-ABDOMINAL URINE EXTRAVASATION. ON (B)(6) 2012, THE PATIENT WAS READMITTED TO THE HOSPITAL AND AN EXPLORATORY LAPAROTOMY PROCEDURE PERFORMED ON THAT SAME DAY CONFIRMED THAT THE PATIENT SUSTAINED A LACERATION TO HER BLADDER; HOWEVER, THE ORIGIN WAS UNDETERMINED. THE BLADDER LACERATION WAS REPAIRED PER UROLOGY. BASED ON THE PATIENT'S DISCHARGE SUMMARY REPORT, THE PATIENT HAD SLOW RETURN OF GI FUNCTION POST-OPERATIVELY WITH IMPROVEMENT IN PAIN AND RESOLUTION OF FEVER. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012, WITH INSTRUCTIONS ON CATHETER CARE AND POSTOPERATIVE CARE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ON (B)(4) 2013, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE DA VINCI HYSTERECTOMY ON (B)(6) 2012. THE CSR INDICATED THAT HE DID NOT OBSERVE ANY MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES DURING THE PROCEDURE. THE CSR ALSO INDICATED THAT HE DID NOT WITNESS THE PATIENT'S BLADDER BEING DAMAGED AT ANY TIME DURING THE SURGICAL PROCEDURE. ON (B)(4) 2013, ISI CONTACTED THE RISK MANAGER OF THE HOSPITAL TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE RISK MANAGER WAS UNWILLING AND UNABLE TO PROVIDE ANY INFORMATION REGARDING THE REPORTED EVENTS. A REVIEW OF THE SYSTEM ERROR LOGS FOR THE DA VINCI SURGICAL SYSTEM WITH A PROCEDURE DATE OF (B)(6) 2012, CONFIRMED THAT 20 MINUTES INTO THE PROCEDURE, THE SURGEON CONSOLE LOST AC POWER AND SWITCHED TO BATTERY BACKUP WITH AN ALARM. AC POWER RETURNED APPROXIMATELY 15 SECONDS LATER. THE FIRST ALARM WAS CLEARED; HOWEVER APPROXIMATELY 5 MINUTES LATER, THE AC POWER WAS LOST AGAIN, BUT WAS RESTORED 8 SECONDS LATER. THE SECOND ALARM WAS CLEARED APPROXIMATELY 1 MINUTE LATER. NO OTHERS ERRORS WERE NOTED TO HAVE OCCURRED." } ], "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": "" } ] }