{ "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": "2955842-2014-01633", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140320", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120510", "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": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140320", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "166873", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140320", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "OH", "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": "20140320", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "89", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20140218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3690146", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140218", "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": "17615155", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2014, INTUITIVE SURGICAL INC.(ISI) RECEIVED AN IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: PATIENT HAD ROBOTIC HYSTERECTOMY, THERE WERE TWO LARGE TEARS IN BOTH RIGHT AND LEFT LATERAL WALLS NEAR THE CUFF." }, { "mdr_text_key": "17717889", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE COMPLICATIONS EXPERIENCED BY THE PATIENT. ISI CONTACTED THE REPORTER AND OBTAINED THE FOLLOWING INFORMATION ON (B)(4) 2014: THE SURGEON WAS PERFORMING A DA VINCI HYSTERECTOMY BILATERAL SALPING-OOPHORECTOMY PROCEDURE WHEN THE PATIENT'S VAGINAL SIDEWALL WAS INJURED. THE REPORTER DOES NOT KNOW HOW LONG THE DA VINCI PROCEDURE WAS IN PROGRESS WHEN THE ALLEGED INJURY OCCURRED TO THE PATIENT. SHE ALSO DID NOT KNOW THE CAUSE OF THE REPORTED INTRA-OPERATIVE INJURY. THE PATIENT'S INJURY WAS REPAIRED USING A 2-0 VICRYL SUTURE. THE PATIENT TOLERATED THE DA VINCI PROCEDURE WELL AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO THE INTRA-OPERATIVE COMPLICATIONS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012 AND NO SYSTEM MALFUNCTION WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE, AND SUFFERED TWO LARGE TEARS IN BOTH RIGHT AND LEFT LATERAL WALLS NEAR THE CUFF. HOWEVER, AT THIS TIME THE CAUSE OF THE INTRA-OPERATIVE COMPLICATIONS IS UNKNOWN." } ], "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": "" } ] }