{ "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": "2955842-2013-03134", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120501", "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": [ "Other", "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "409962", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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 A60.P8", "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": "20250806", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES, ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Fever", "Swelling" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305510", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "11065874", "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 PROVIDED INFORMATION, THERE IS NO EVIDENCE THAT A MALFUNCTION OCCURRED WITH THE DA VINCI SI SYSTEM, INSTRUMENTS, OR ACCESSORIES. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, 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 AFTER UNDERGOING A DA VINCI SI SURGICAL HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "3588426", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012 FOR ENDOMETRIAL ADENOCARCINOMA. ACCORDING TO THE OPERATIVE NOTES, THE PATIENT HAD A NORMAL SIZE APPROXIMATELY 6 WEEK UTERUS WITH NORMAL BILATERAL TUBES AND OVARIES, NO GROSS LESIONS SEEN. THERE WAS A MINIMAL AREA OF ADENOCARCINOMA SEEN IN THE ENDOMETRIUM; HOWEVER, NO MYOMETRIAL INVASION WAS PRESENT. ALL LYMPH NODES WERE NORMAL IN APPEARANCE WITH NO EVIDENCE OF METASTATIC DISEASE. NO DAMAGE TO BOWEL, BLADDER, OR BLOOD VESSELS WAS NOTED THROUGHOUT THE PROCEDURE. THE PATIENT DID NOT HAVE ANY COMPLICATIONS DURING THE PROCEDURE AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. THERE WAS NO ALLEGATION OR REPORT OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES IN THE OPERATIVE REPORT. THE POST OPERATIVE HOSPITAL COURSE WAS WITHOUT COMPLICATION AND THE PATIENT WAS DISCHARGED ON (B)(6) 2012 IN STABLE CONDITION. ACCORDING TO THE MEDICAL RECORD, APPROXIMATELY 2 WEEKS AFTER THE DA VINCI SURGICAL PROCEDURE ((B)(6) 2012), THE PATIENT WENT TO THE HOSPITAL WITH COMPLAINTS OF INCREASED ABDOMINAL PAIN AND HIGH FEVER. THE CT SCAN OF ABDOMEN AND PELVIS WAS PERFORMED AND REVEALED THERE WERE MULTIPLE INTRA-ABDOMINAL FLUID COLLECTIONS, CONSISTENT WITH A POSSIBLE ABSCESS. THE PATIENT UNDERWENT IR DRAINAGE AND WAS TREATED WITH PAIN MEDICATIONS AND ANTIBIOTICS. OVER THE NEXT FEW DAYS THE PATIENT UNDERWENT ANTIBIOTIC TREATMENT UNTIL HER SYMPTOMS IMPROVED. SHE WAS DISCHARGED ON (B)(6) 2012. AFTER GOING HOME, SHE CONTINUED TO HAVE FEVERS AND SIGNIFICANT BOUTS OF PAIN. ON (B)(6) 2012 THE PATIENT HAD AN OUTPATIENT PROCEDURE TO ATTEMPT TO DRAIN THE ABSCESS, BUT THIS WAS UNSUCCESSFUL DUE TO A BLOOD VESSEL BEING IN THE WAY. THE PATIENT REPORTEDLY CONTINUED TO HAVE OCCASIONAL BOUTS BACK AND FORTH VISITS TO THE HOSPITAL THROUGH THE SUMMER. ON (B)(6) 2012, AS PER THE LEGAL DOCUMENTATION (NO MEDICAL RECORD INFORMATION WAS PROVIDED) THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SIGNIFICANT PELVIC AND ABDOMINAL PAIN AND HAD A DIAGNOSIS OF POSSIBLE ABSCESS. SHE RECEIVED IV ANTIBIOTICS AND DRAINAGE OF MASS PERFORMED BY CT GUIDANCE. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED WITH A DRAIN AND HAD DRAIN FOR 11 DAYS UNTIL IT WAS REMOVED BY THE DOCTOR. PATIENT'S CURRENT CONDITION WAS NOT PROVIDED." } ], "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": "" } ] }