{ "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": "2955842-2013-01842", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130524", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20130226", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "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": "20130528", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "231141", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130524", "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 A5.1P7", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20130524", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Life Threatening", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Inflammation", "Septic Shock", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20130426", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3130866", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130426", "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": "10739115", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE DA VINCI S HYSTERECTOMY PROCEDURE. THE CSR INDICATED THAT HE DID NOT OBSERVE ANY MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE SURGICAL PROCEDURE. THE CSR REPORTEDLY SPOKE TO THE SURGEON, WHO PERFORMED THE HYSTERECTOMY PROCEDURE, REGARDING THE PATIENT'S RETURN TO THE HOSPITAL ON (B)(6) 2013. THE SURGEON REPORTEDLY INFORMED THE CSR THAT THE MARK ON THE PATIENT'S BOWEL APPEARED TO BE CYLINDRICAL IN SHAPE AND WAS SMALLER THAN THE SIZE OF A DIME. THE SURGEON ALSO REPORTEDLY INFORMED THE CSR THAT THE MARK APPEARED TO BE A BURN MARK THAT WAS MORE SUPERFICIAL. ACCORDING TO THE CSR, THE SURGEON CONCLUDED THAT THE BURN MARK WAS PROBABLY DUE TO AN INSTRUMENT USED DURING THE HYSTERECTOMY PROCEDURE. THE CSR INDICATED THAT THERE WAS NO EVIDENCE THAT THE PATIENT'S BOWEL WAS PERFORATED. DURING THE EXPLORATORY LAPAROTOMY PROCEDURE, THE SECOND DOCTOR REMOVED THE PATIENT'S APPENDIX DUE TO BEING INFLAMED. THE CSR DID NOT KNOW THE CURRENT STATUS OF THE PATIENT. INTUITIVE SURGICAL HAS MADE SEVERAL ATTEMPTS 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. BASED ON THE INFORMATION PROVIDED, THERE IS NO CLEAR EVIDENCE AS TO WHAT CAUSED OR CONTRIBUTED TO THE PATIENT'S SEPTIC SHOCK, THE ALLEGED BURN MARK, OR THE INFLAMMATION OF THE PATIENT'S APPENDIX." }, { "mdr_text_key": "3451674", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2013, AND ON (B)(6) 2013, THE PATIENT ALLEGEDLY EXPERIENCED SEPTIC SHOCK. THE SURGEON INDICATED THAT THE HYSTERECTOMY PROCEDURE WENT WELL AND HE DID NOT OBSERVE ANY ERRORS DURING THE CASE. ACCORDING TO THE SURGEON, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) IN SEPTIC SHOCK ON (B)(6) 2013, AND A SECOND DOCTOR PERFORMED A DIAGNOSTIC LAPAROTOMY. DURING THE DIAGNOSTIC LAPAROTOMY, THE SURGEON WHO PERFORMED THE HYSTERECTOMY PROCEDURE WAS PRESENT. HE CLAIMED THAT NO FACTORS WERE IDENTIFIED FOR THE CAUSE OF THE SEPSIS DURING THE DIAGNOSTIC LAPAROTOMY. THE SECOND DOCTOR THEN PERFORMED AN EXPLORATORY LAPAROTOMY PER THE REQUEST OF THE SURGEON SINCE THE PATIENT WAS IN SEPSIS. DURING THE EXPLORATORY LAPAROTOMY, THE PATIENT'S APPENDIX WAS FOUND TO BE INFLAMED AND A SMALL MARK WAS OBSERVED ON THE PATIENT'S BOWEL. THE SURGEON DENIED THAT FECES WAS OBSERVED IN THE PATIENT'S ABDOMINAL CAVITY. THE SECOND DOCTOR REPORTEDLY APPLIED SEVERAL SUTURES OVER THE SMALL MARK ON THE PATIENT'S BOWEL AND A TEMPORARY DIVERTING ILEOSTOMY WAS CREATED." } ], "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": "" } ] }