{ "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": "2955842-2013-04984", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120516", "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": [ "Invalid data" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "561864", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20131101", "sequence_number_treatment": [ "DAV SI SURG SYS INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "36 YR", "patient_sex": "", "patient_weight": "77", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Pain", "Organ Dehiscence" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444432", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "3857035", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6), 2012 DUE TO MENORRHAGIA, PELVIC PAIN AND HYDROSALPINX. ISI WAS PROVIDED WITH THE PATIENT'S PRIMARY OPERATIVE REPORT. ADDITIONAL INFORMATION REGARDING THE PATIENT WAS PROVIDED IN THE PATIENT'S ATTORNEY CLAIM FORM. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ACCORDING TO THE INFORMATION PROVIDED IN THE PATIENT'S CLAIM FORM, ON (B)(6), 2012, THE PATIENT EXPERIENCED HEAVY BLEEDING AND WAS HAVING PAIN. THIS OCCURRED AFTER PICKING UP HER (B)(6) CHILD. THE PATIENT WAS INFORMED TO GO TO ER FOR URTGENT CARE EVALUATION. REPORTEDLY, ON (B)(6), 2012 THE PATIENT PRESENTED TO THE ER, COMPLAINING OF PAIN AFTER ENGAGING IN INTERCOURSE THE PREVIOUS NIGHT. THE PATIENT WAS EVALUATED AND IT WAS DISCOVERED THAT THE PATIENT HAD CUFF SEPARATION. SEROSAGINOUS FLUID IN THE VAULT, CUFF DEHISCED. THE PATIENT UNDERWENT A PROCEDURE TO REPAIR HER CUFF. ON (B)(6) 2012, THE PATIENT CONTACTED HER HEALTHCARE PROVIDER COMPLAINING OF BLEEDING; HOWEVER, THE BLEEDING CEASED THAT DAY. ON (B)(6) 2012, THE PATIENT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF PAIN AFTER ENGAGING IN COITUS. REPORTEDLY, EXAMINATION OF THE PATIENT FOUND THAT THE PATIENT HAD VAGINAL CUFF DEHISCENCE AND HER SMALL BOWEL WAS PROTRUDING THROUGH THE DEFECT. ON (B)(6) 2012, THE PATIENT'S VAGIAL CUFF WAS REPAIRED. ON (B)(6) 2012 DURING A FOLLOW UP VISIT THE PATIENT WAS FOUND TO NEED PELVIC REST. ON (B)(6) 2012, DURING A FOLLOW UP VISIT, THE PATIENT WAS NO LONGER BLEEDING, BUT COMPLAINED OF PAIN. DURING FOLLOW UP EVALUATIONS ON (B)(6) 2012, THE PATIENT'S CUFF INCISION WAS FOUND TO HAVE A KNOT AND OOZING. ON (B)(6) 2012, DURING THE PATIENT'S FOLLOW UP EXAMINATION, IT WAS DETERMINED THAT THE PATIENT'S CUFF WAS WELL HEALED TO GO TO WORK. THE PATIENT WAS ADVISED THAT SHE COULD RESUME COITUS THE FOLLOWING WEEK." }, { "mdr_text_key": "11215388", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE 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. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST SURGICAL COMPLICATIONS FOLLOWING A DA VINCI SURGICAL 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": "" } ] }