{ "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": "2955842-2013-03173", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110407", "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" ], "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": "413332", "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 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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250724", "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 AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "35 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Fever", "Chills", "Discharge", "Discomfort", "Injury" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305823", "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": "3712973", "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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT DEVELOPED A PELVIC ABSCESS AS A RESULT OF UNDERGOING THE SURGICAL PROCEDURE AND WAS HOSPITALIZED. THE PATIENT'S PROCEDURE NOTES STATE THAT THE PRE-OPERATION DIAGNOSIS WAS SYMPTOMATIC UTERINE FIBROIDS, PELVIC PAIN, AND MENOMETRORRHAGIA. THE PATIENT WAS NOTED TO HAVE A RELATIVELY LARGE UTERUS, APPROXIMATELY 16 WEEKS WITH ONE LARGE \"FUNDUAI\" FIBROID. OVARIES AND TUBES REPORTED TO BE NORMAL. AFTER REMOVAL OF THE UTERUS, A SMALL VAGINAL LACERATION WAS NOTED TO BE REPAIRED WITH 2.0 VICRYL WITHOUT INCIDENT. THE VAGINAL CUFF WAS CLOSED USING THE V-LOC RUNNING SUTURE WITH REPORTED EXCELLENT CLOSURE. THERE WERE NO SIGNS OF LEAKAGE OF URINE AND NO REPORTED EVIDENCE OF INJURY. THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 (ONE DAY AFTER SURGERY) WITH NO REPORTED COMPLICATIONS. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM WITH SYMPTOMS OF FEVER, CHILLS, AND INCREASED ABDOMINAL DISCOMFORT ON (B)(6) 2011. A CT SCAN REVEALED THAT THE PATIENT HAD A BOWEL INJURY. ON (B)(6) 2011, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, ABDOMINAL WASHOUT AND DRAINAGE OF THE VAGINAL CUFF ABSCESS, HOWEVER, THERE WAS NO EVIDENCE OF AN INJURY TO HER BOWEL. THE PATIENT WAS HOSPITALIZED FOR 8 DAYS FOR TREATMENT OF THE ABSCESS. THE PATIENT WAS DISCHARGED HOME WITH ORAL ANTIBIOTICS ON (B)(6) 2011. THE PATIENT'S DISCHARGE SUMMARY STATES THAT SHE HAD A VERY LIGHT AMOUNT OF WOUND DRAINAGE BUT NO SIGNS OF INFECTION. NO FURTHER CLINICAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE FROM THE HOSPITAL ON (B)(6) 2011." }, { "mdr_text_key": "11019420", "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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT HAD A BOWEL INJURY WHICH WAS DISCOVERED AFTER A DA VINCI 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": "" } ] }