{ "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": "2955842-2015-01383", "type_of_report": [ "" ], "product_problem_flag": "N", "date_received": "20151113", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20151007", "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": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20151113", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "753164", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20151113", "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 A6.0P8", "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "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": "20151113", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Fever", "Renal Failure", "Sepsis", "Injury" ] } ], "distributor_city": "", "date_report": "20151015", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5223423", "removal_correction_number": "", "number_devices_in_event": "", "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": "31196016", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED OPERATIVE COMPLICATION SUSTAINED BY THE PATIENT. THERE IS NO ALLEGATION, AT THIS TIME, THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI 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. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S ALLEGED INTRA-OPERATIVE INJURY. AS OF THE DATE OF THIS COMPLAINT, THERE HAVE BEEN NO REPORTED COMPLAINTS REGARDING THE INSTRUMENTS USED DURING THE DA VINCI SURGICAL PROCEDURE INVOLVED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY THAT WAS SUBSEQUENTLY REPAIRED. HOWEVER, AT THIS TIME, THE CAUSE OF THE ALLEGED BOWEL INJURY IS UNKNOWN." }, { "mdr_text_key": "31196017", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH HIGH TEMPERATURES AND WAS VERY SICK. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S BOWEL HAD BEEN REPORTEDLY NICKED AND THE PATIENT UNDERWENT ADDITIONAL SURGERY TO REPAIR THE BOWEL INJURY. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: SHE WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. DURING THE SURGICAL PROCEDURE, THERE WERE NO REPORTS OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES. THE SURGICAL PROCEDURE WAS COMPLEX DUE TO EXTENSIVE ADHESIONS. THE PATIENT'S UTERUS WAS STUCK TO THE BOWEL AND SIDEWALL. THE SURGICAL PROCEDURE WAS COMPLETED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT RETURNED TO THE HOSPITAL AND WAS VERY SICK. A GENERAL SURGEON PERFORMED EXPLORATORY SURGERY AND FOUND AN UNSPECIFIED BOWEL INJURY THAT WAS REPAIRED. THE DETAILS REGARDING THE TYPE OF BOWEL INJURY SUSTAINED AND THE REPAIR PERFORMED WERE NOT KNOWN. THE CSR INDICATED THAT SHE SPOKE TO THE SURGEON AND THE SURGICAL FIRST ASSIST REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, THE SURGEON AND SURGICAL FIRST ASSISTANT COULD NOT PROVIDE A POSSIBLE CAUSE OF THE BOWEL INJURY. ON (B)(6) 2015, THE CSR SPOKE TO THE SURGEON AND WAS INFORMED THAT THE PATIENT WAS STILL IN THE ICU. THE PATIENT IS CURRENTLY UNDERGOING DIALYSIS AS A RESULT OF RENAL FAILURE DUE TO SEPSIS. ACCORDING TO THE SURGEON, THE PATIENT WAS SLOWLY GETTING BETTER. IN ADDITION, THE SURGEON BELIEVES THE BOWEL INJURY OR NICK MIGHT HAVE OCCURRED DURING TAKE-DOWN OF ADHESIONS DURING THE BEGINNING PART OF THE SURGICAL PROCEDURE. THE CSR REITERATED THAT THERE WAS NO CLAIM THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM 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": "" } ] }