{ "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": "2955842-2013-04605", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131024", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130919", "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": "20131025", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "546596", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131024", "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": [ "Arcing" ], "reporter_state_code": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20131024", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20130924", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3428314", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130924", "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": "3791810", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION ABOUT A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL BECAUSE FECAL MATTER WAS FOUND IN HER VAGINAL CANAL. THE PATIENT UNDERWENT A SMALL BOWEL REPAIR AND CURRENTLY HAS A COLOSTOMY. THE SITE REPORTED THERE WAS POSSIBLE UNINTENDED ARCING. NO OTHER DETAILS WERE PROVIDED AT THIS TIME. ON (B)(6) 2013, ISI SPOKE WITH ONE OF THE SITE'S CONTACTS AND OBTAINED ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2013, WHICH WAS 2 DAYS AFTER THE DA VINCI HYSTERECTOMY PROCEDURE. HE WAS UNABLE TO PROVIDE ANY DETAILS REGARDING THE PATIENT'S CONDITION BEFORE THE RE-ADMISSION. HE STATED THAT THE GENERAL SURGEON WHO PERFORMED THE SMALL BOWEL REPAIR BELIEVES THAT THE INJURY WAS ATTRIBUTED TO PULL AND TUG ISSUES AND NOT DUE TO A THERMAL INJURY. HE WAS UNABLE TO CONFIRM OR DENY IF THERE WERE ANY MALFUNCTIONS OF THE DA VINCI SYSTEM, INSTRUMENTS, AND OR ACCESSORIES THAT COULD HAVE CONTRIBUTED TO THE PATIENT'S INJURIES AND ADVISED ISI TO CONTACT THE ROBOTICS COORDINATOR, WHO WAS CURRENTLY OUT OF THE OFFICE, FOR MORE INFORMATION. ISI WILL CONTACT THE SITE'S ROBOTICS COORDINATOR AT A FUTURE DATE AND SUBMIT A FOLLOWUP MDR IF NEW INFORMATION IS OBTAINED." }, { "mdr_text_key": "11097628", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THERE WAS A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES. HOWEVER, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL HYSTERECTOMY PROCEDURE." } ], "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": "" } ] }